Key Responsibilities:

Sample Handling and Documentation:

• Receive and log incoming samples, ensuring accurate and complete documentation.
• Prepare samples for analysis, including labeling, aliquoting, and distribution to appropriate testing areas.

Sample Storage and Transport:

• Manage the storage of samples in designated locations, maintaining proper environmental conditions (e.g., temperature, humidity).
• Retrieve and transport samples as needed for testing or further processing, ensuring traceability and chain of custody.

Compliance and Quality Checks:

• Adhere to all relevant SOPs, regulatory requirements, and quality standards in sample management.
• Perform regular quality checks and audits of sample storage areas to ensure compliance and integrity.

Record Keeping and Reporting:

• Maintain accurate and up-to-date records in sample management databases or systems.
• Generate reports on sample status, inventory levels, and other metrics as required.

Equipment Maintenance:

• Ensure that all sample management equipment (e.g., freezers, refrigerators, spectrophotometer) is properly maintained and calibrated.
• Coordinate with maintenance and repair services as needed.

Training and Mentorship:

• Train junior technicians and new staff on sample management procedures and best practices.
• Provide ongoing support and mentorship to team members, fostering a collaborative and efficient work environment.

Inventory Management:

• Monitor and manage inventory levels of sample-related supplies (e.g., tubes, labels, reagents).
• Place orders for supplies and manage relationships with vendors.

Issue Resolution:

• Address and resolve issues related to sample management, such as discrepancies, sample damage, or equipment malfunctions.
• Implement corrective actions to prevent recurrence of issues.

Qualifications:

• Experience in sample management within a GMP environment.
• Strong understanding of laboratory equipment management.
• Excellent organizational and communication skills.
• Ability to maintain compliance with GMP guidelines and protocols.
• Proficiency in maintaining stock and ordering supplies.

Additional Information:

• This role requires effective communication with stakeholders to ensure proper maintenance and timely escalation of equipment qualifications.
• The position may involve working at multiple sites and coordinating with various departments.

Our Offer:

• A full-time position with a competitive salary.
• A budget of 16.66% (holiday allowance and year-end bonus) of your gross salary, which can be used monthly.
• Flexible working hours, in consultation.
• Personal training budget of €2,100 every 3 years.
• Contribution to travel expenses from the first kilometer.
• Good accessibility by public transport, with private parking available.
• Pension scheme with Zorg & Welzijn.

Key Responsibilities

Leadership & Team Development

• Guide and inspire the Global QC team, ensuring effective collaboration and resource allocation.
• Recruit, coach, and evaluate team members, promoting professional growth and knowledge sharing.
• Translate annual departmental objectives into actionable team and individual goals, driving measurable outcomes.

Quality Assurance & Oversight

• Maintain oversight of quality systems, ensuring compliance with national and international pharmaceutical laws and regulations.
• Address deviations and bottlenecks proactively, aligning methods, validations, and processes with regulatory requirements and business goals.
• Spearhead investigations and implement solutions to ensure operational integrity.

Stakeholder Engagement

• Collaborate with stakeholders to align expectations, deliver project objectives, and communicate effectively.
• Develop and execute communication plans to ensure transparency and engagement across global projects.

GxP Compliance & Decision-Making

• Serve as a key decision-maker regarding GxP matters, including batch dispositions and change control.
• Stay informed on emerging regulatory GxP requirements, ensuring compliance through robust training and SOP management.

Qualifications & Skills

Education & Experience

• Bachelor’s degree in Chemistry, Biology, Pharmacy, or a related field.
• Minimum 2 years of leadership experience in a quality control environment.
• At least 5 years of Quality Control experience, with solid knowledge of GMP and GDP guidelines.

Competencies

• Strong initiative and problem-solving abilities, with a proactive approach to quality improvements.
• Exceptional interpersonal and communication skills to manage teams and engage stakeholders.
• Analytical mindset with attention to detail for coordinating investigations and ensuring compliance.
• Fluent in English (spoken and written); knowledge of French and/or Dutch is a plus.

Personal Attributes

• Integrity in handling confidential quality data.
• Organised and systematic approach to work.
• A commitment to fostering a safe work environment and a culture of operational excellence.
• Representative demeanour to maintain and enhance internal and external relationships.

What We Offer

• A collaborative, innovative environment within a leading pharmaceutical organisation.
• Opportunities for professional development and growth.
• Competitive remuneration and benefits.

Apply Today

If you are passionate about quality and innovation and are ready to take the next step in your career, we would love to hear from you. Submit your application and join us in shaping the future of biosolutions.

The Role:

As the Manager Asset Engineering, you will be leading a team of approximately 10 seasoned professionals. This is a leadership position where you’ll need to assess the strengths within the team, restructure where needed, and ensure that facilities and assets are maintained to the highest standard. You will be responsible for aligning your team with the company’s goals and driving both internal and external collaborations with suppliers and other campus users.

Key Responsibilities:

Lead and manage a team of around 10 employees, with a focus on prioritising tasks and unlocking their potential.

Assess and restructure the current team, identifying areas for talent development and adjusting roles where necessary.

Provide leadership by creating a structured and clear framework that guides the team towards success.

Work closely with external partners, including suppliers and other campus users, to ensure seamless operations.

Engage in strategic conversations and represent your team effectively in tactical discussions regarding the campus.

Handle a complex budget and ensure that financial decisions are well justified and aligned with company expectations.

What You’ll Bring:

A team player who enjoys leading and guiding teams toward their best performance.

Proactive and entrepreneurial, with a strong sense of urgency and an ability to navigate through challenges with minimal internal support.

Strong in communication, both with your internal team and external stakeholders, ensuring smooth collaboration on all levels.

Adaptable and strategic, with a talent for spotting inefficiencies and proposing effective solutions.

Your Background:

Education: Technical college education or equivalent, ideally with knowledge of facility management or asset engineering.

Experience: At least 5 years of relevant experience, including time spent in management roles, preferably in a pharmaceutical or healthcare setting.

Skills: Ability to lead, communicate effectively, and manage both people and processes in a dynamic, high-stakes environment.

What do we offer you?

Team: You will work in a dynamic, diverse, and close-knit team.

Generous Time Off: 30 vacation days, some of which can be flexibly used in exchange for the purchase of a bicycle, training, or paid out, etc.

Development: A training budget of €2,100 every 3 years to deepen your knowledge.

Travel Allowance: From the first kilometre (€0.23 per km, max. 30 km).

Pension Plan: A solid pension scheme through PFZW.

Why Prothya Biosolutions?

At Prothya Biosolutions, you will be part of an innovative team that values leadership, collaboration, and continuous improvement. You will play a key role in ensuring that our facilities are safe, efficient, and optimised for production, all while contributing to the delivery of critical healthcare products.

Join us and help us continue our mission of Creating Value, Sustaining Life.

Doel van de functie

• Je gaat leidinggeven aan een team en kwaliteitscondities uitvoeren van productiewerkzaamheden met bloed en/of bloedproducten en daaruit gefabriceerde (tussen)producten, waaronder een aantal in aard verschillende, veelal dagelijks terugkerende productiehandelingen;
• Je zorgt voor kennisoverdracht aan collega’s en medewerkers door onder andere het geven van presentaties, het (doen) verzorgen van trainingen en het inwerken van nieuwe gebruikers;
• Je adviseert de leidinggevende over mogelijke modificaties in en verbeteringen van het proces in het betreffende aandachtsgebied;
• Je doet de ‘troubleshooting’ bij problemen en overlegt daarover met derden;
• Je voert controles uit op producten, processen en (hulp)materialen, onder andere door bemonstering en schouwing;
• Schrijft validatie- en kalibratieprotocollen en kwaliteitsdocumenten.

Jouw profiel

• Hbo-diploma;
• 3 jaar ervaring in een leidinggevende functie, bij voorkeur in de farmaceutische industrie, 3-4 jaar ervaring bij de productie van geneesmiddelen;
• Kennis van microbiologie voor het werken in geconditioneerde ruimtes en aseptische bereidingen, reinigings- en sterilisatietechnieken, kennis van scheidingstechnieken waaronder precipitatie, chromatografie en filtratie;
• Extra vakkennis voor het beheer van het specialistisch productieproces;
• Kennis van vigerende kwaliteitssystemen, richtlijnen en procedures;
• Verhoogt eigen kennisniveau door actieve deelname aan cursussen en bijscholingsprogramma’s.

Ons aanbod:

• Een fulltime functie met een concurrerend salaris.
• Een budget van 16,66% (vakantietoeslag en eindejaarsuitkering) van je bruto salaris, dat maandelijks kan worden gebruikt.
• Flexibele werktijden, in overleg.
• Persoonlijk opleidingsbudget van €2.100 elke 3 jaar.
• Bijdrage aan reiskosten vanaf de eerste kilometer.
• Goede bereikbaarheid met het openbaar vervoer, met privéparkeermogelijkheden beschikbaar.
• Pensioenregeling bij Zorg & Welzijn.

Belangrijkste verantwoordelijkheden

• Projectmanagement binnen Change Control: Begeleiden van en bijdragen aan change control-projecten binnen de productieomgeving. Je vertegenwoordigt de QA-afdeling in projectteams en zorgt ervoor dat de validatie-eisen en kwaliteitsrichtlijnen worden nageleefd.
• Compliance en Advies: Acteren als Subject Matter Expert (SME) op het gebied van compliance en kwaliteitsborging. Je beoordeelt en bewaakt de kwaliteitsimpact van veranderingen en adviseert interne teams tijdens audits en inspecties.
• Data Integriteit en Master Data Management: Waarborgen van de naleving van change control-processen, inclusief de controle op documentatie, rapportages en systemen. Je beheert Master Data en zorgt voor volledige, correcte rapportages in lijn met interne en externe eisen.
• Beleid Ontwikkelen en Implementeren: Ontwikkelen en uitrollen van beleid voor change control binnen de organisatie. Je vertaalt strategieën naar praktische richtlijnen en biedt training en begeleiding aan collega’s om kwaliteitsstandaarden te bevorderen.
• Stakeholder Management: Coördineren en afstemmen met interne en externe stakeholders. Je weet draagvlak te creëren voor kwaliteitsinitiatieven en bevordert samenwerking door tactvol en overtuigend op te treden.

Jouw profiel

• Wij zoeken een QA Project Specialist met uitstekende analytische en organisatorische vaardigheden, die communicatief sterk is en zich thuis voelt in een dynamische omgeving. Daarnaast herken jij je in het volgende profiel:
• HBO-opleiding in een technische, chemische of biotechnologische richting.
• Minimaal 3 jaar werkervaring binnen kwaliteitsmanagement of QA in een cGMP-omgeving, bij voorkeur in de farmaceutische sector of life sciences.
• Grondige kennis van cGMP-richtlijnen en ervaring met change control- en validatieprocessen.
• Proactieve houding en een gestructureerde werkwijze, met het vermogen om beslissingen te nemen binnen complexe projectomgevingen.
• Uitstekende mondelinge en schriftelijke communicatievaardigheden in Nederlands en Engels.
• Ervaring met het leiden van projecten en het coördineren van multidisciplinaire teams.

Wat bieden wij?

• Bij Prothya Biosolutions krijg je de kans om deel uit te maken van een gedreven team dat het verschil maakt in de gezondheidszorg. Wij bieden:
• Een uitdagende en verantwoordelijke positie waarin jouw expertise en ideeën welkom zijn.
• Mogelijkheden voor professionele ontwikkeling en training, zowel op de korte als lange termijn.
• Een competitief salaris, aangevuld met uitstekende secundaire arbeidsvoorwaarden.

Interesse?

Ben je enthousiast om als QA Project Specialist aan de slag te gaan bij Prothya Biosolutions? Solliciteer nu en help ons onze kwaliteitsdoelen te bereiken!

Your responsibilities:

• Ensure the sterility of Prothya’s products by designing, implementing, and monitoring processes and control systems to prevent and control microbial contamination.
• Collaborate closely with both the production and quality departments to ensure compliance with regulations and industry standards, such as those described in Annex 1.
• Evaluate processes, systems, and equipment, including setting up Environmental and Utility Monitoring programs and establishing the Contamination Control Strategy (CCS).
• Provide advice on product sterility and contamination control, assess deviations posing potential hazards to sterility, and contribute to investigations and root cause analyses of microbiological issues.
• Lead the Contamination Control Board and co-ordinate microbial services.
• Support microbial assurance aspects of the Quality System and review/develop procedures for microbial assurance activities.
• Implement GMP training programs for cleanroom and other relevant staff.
• Act as the Subject Matter Expert for Contamination Control during audits and inspections.
• Lead multidisciplinary projects in the area of microbial assurance.

Your profile:

• BSc degree or higher in a relevant field (pharmaceuticals, microbiology, biology, etc.).
• At least 10 years of experience within a pharmaceutical production environment.
• Strong microbiological knowledge and experience implementing EU requirements, including Annex 1, and setting up a Contamination Control Strategy.
• Proven experience with contamination control processes.
• Proactive team player with excellent communication and influencing skills.
• Experience conducting GMP audits, both internal and external.
• Fluent in English; proficiency in Dutch is a plus.

What we offer:

• A competitive salary between €75,000 and €90,000 per year, depending on experience.
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• Flexible working hours in consultation.
• Personal training budget of €2,000 every 3 years.
• Contribution to travel expenses from the first kilometre.
• Good accessibility by public transport and private parking.
• Pension plan with Zorg & Welzijn.

More info:

If you would like to know more about this vacancy, please contact our recruitment department via careers.nl@prothya.com. Do you recognise yourself in this profile and want to take on this challenge at Prothya Biosolutions? Then we’d love to receive your resume and motivation letter via the apply button on this page. We aim to respond within a week.

Key Responsibilities:

Analysis & Documentation:

• Collaborate with users to identify and document system requirements.
• Analyze business processes to identify improvement opportunities.
• Prepare detailed specifications for new systems or system changes.
• Act as lead analyst for strategic initiatives involving cross-domain processes.
• Coach junior analysts in requirements gathering, documentation, and standards.

System Design & Development:

• Design IT solutions that meet business needs and specifications.
• Collaborate with development teams to evaluate the technical feasibility of proposed solutions.
• Supervise the development and implementation of IT solutions.
• Ensure business requirements are aligned with enterprise architecture and long-term IT strategy.
• Provide deep business context and process insights to shape high-impact IT solutions.

Evaluation and Optimization of Systems:

• Assess existing systems to identify opportunities for improvement.
• Analyze system performance and user feedback to suggest optimizations.
• Test new systems and system changes to ensure proper operation and compliance.
• Lead improvement initiatives based on system insights and usage patterns.
• Advise on tool selection and innovation to improve user efficiency and data insights.

Cooperation and Coordination:

• Collaborate with Project Managers to translate problems into actionable projects.
• Coordinate with other Business Analysts, architects, and management to ensure consistency and synergy in IT solutions.
• Contribute to the development of data use and analysis strategies.
• Lead coordination between departments on complex process transformations.
• Support governance structures and ensure alignment with the IT roadmap.

Stakeholder Management:

• Identify and manage the expectations of various stakeholders, both internal and external.
• Facilitate meetings and communication to ensure alignment of all parties.
• Engage with senior stakeholders and management.
• Facilitate prioritization and decision-making on conflicting needs.

Qualifications:

• Master’s or Bachelor’s degree.
• Minimum of 7 years of experience in Pharma-related functions, as a business analyst or business consultant.
• Strong understanding of IT processes and affinities with applications and software solutions.

Skills:

• Requirements Analysis: Expert proficiency in gathering, analysing, and documenting business requirements.
• Business Process Modeling: Expertise in developing and optimizing business processes.
• Systems Analysis: Proficient in analysing existing systems and identifying areas for improvement.
• Data Analysis: Proficiency in analysing business data to provide insights and support strategic decision-making.
• Technical Knowledge: Advanced understanding of IT systems, applications, and infrastructure.
• Communication Mastery: Excellent oral and written communication skills.
• Problem-Solving: Strong problem-solving skills, including critical thinking and innovative solution development.
• Documentation: Expertise in creating detailed documentation, including requirements, process flows, and system specifications.
• Attention to Detail: Precision in analysing details and ensuring accuracy in documentation and solutions.
• Customer Orientation: Strong focus on meeting the needs and expectations of stakeholders and users.

Additional Information:

• Takes GxP requirements into account during activities.
• Follows mandatory GxP training.
• Identifies and escalates GxP issues.

Our Offer:

• A full-time position with a competitive salary.
• A budget of 16.66% (holiday allowance and year-end bonus) of your gross salary, which can be used monthly.
• Flexible working hours, in consultation.
• Personal training budget of €2,100 every 3 years.
• Contribution to travel expenses from the first kilometer.
• Good accessibility by public transport, with private parking available.
• Pension scheme with Zorg & Welzijn.

Purpose of the Job: As a Senior Engineering Specialist, you will act as the process and technical specialist for our lyophilization and filling processes. You are responsible for troubleshooting, optimizing, development and validation of the freeze dryers and filling lines, in close collaboration with Production, Technical Engineering, and QA/Validation stakeholders. In this role, you are capable of acting as the SME in several multidisciplinary projects, providing strategic technical guidance, and ensuring compliance with national and international quality standards.

Key Accountabilities:

• Identifying and solving process or technical issues arising during routine production.
• Providing key input for all changes related to Freeze Driers and Filling lines.
• Monitoring and interpreting regulatory developments and industry trends, and translating these into process improvements.
• Developing and implementing SOPs and production documentation based on industry standards and requirements (e.g., EU GMP Annex I).

Required Background:

• Master’s degree in Chemical Engineering, Biomedical Engineering, or a similar discipline.
• Over 5 years of experience in the pharmaceutical industry in a similar role.
• Solid knowledge of Aseptic filling and Lyophilization and proven experience therein.
• Solid knowledge of process validation and proven experience therein.
• Knowledge of up-to-date industry guidelines.
• Knowledge of airflow visualization studies is a plus.

Personal Characteristics:

• Flexible and energetic, with strong perseverance.
• Capable of handling a dynamic environment with changing priorities.
• Hands-on, present on the shop floor when needed.

Challenges:

• Able to find pragmatic solutions within time and budget constraints.
• Capable of following production priorities and understanding the bigger picture.

Expectations:

• Ready to make an immediate impact.

Our Offer:

• A full-time position with a competitive salary.
• A budget of 16.66% (holiday allowance and year-end bonus) of your gross salary, which can be used monthly.
• Flexible working hours, subject to agreement.
• Personal training budget of €2,100 every 3 years.
• Contribution to travel expenses from the first kilometer.
• Good accessibility by public transport, with private parking options available.
• Pension plan with Zorg & Welzijn.

Functieomschrijving: Als QA Systems Assistant speel je een cruciale rol in het ondersteunen van de integriteit en naleving van onze kwaliteitsmanagementsystemen. Je bent verantwoordelijk voor intern toezicht en het ondersteunen van de QA Systems Officer bij diverse kwaliteits- en nalevingsactiviteiten.

Belangrijkste verantwoordelijkheden:

• Uitvoeren van taken met betrekking tot het eDMS voor het beheer van proceduredocumenten, zorgen voor afstemming met de voorgeschreven procedures die van toepassing zijn op het proces van proceduredocumenten.
• Gebruikersbeheer voor het eDMS
• Opslaan en distribueren van procedure- en instructiedocumenten in overeenstemming met de procedures die van toepassing zijn op het proces van proceduredocumenten.
• Voorbereiden en onderhouden van documentatie met betrekking tot kwaliteitsmanagementsystemen.
• Hard Copy Management voor proceduredocumenten.
• Optreden als trainer voor eDMS-gebruikers (OJT-maker/revisor, OJT-gestuurd afdrukken).

Kwalificaties:

• Bachelor diploma of gelijksoort ervaring
• Goed administratief onderlegd, bereid om administratieve taken uit te voeren
• Ervaring met een documentatiemanagement systeem (master control) is een pluspunt
• Basiskennis van GMP (Good Manufacturing Practices)
• Ervaring hebben met het overbrengen van kennis aan de hand van on the job trainingen.
• Sterke communicatie- en interpersoonlijke vaardigheden.
• Vermogen om zelfstandig en als onderdeel van een team te werken.
• Detailgericht met een toewijding aan kwaliteit en nauwkeurigheid.
• Voertaal Nederlands, Engels is een plus punt.

Wat wij bieden:

• Een fulltime positie met een competitief salaris.
• Een budget van 16,66% (vakantietoeslag en eindejaarsbonus) van je bruto salaris, dat maandelijks kan worden gebruikt.
• Flexibele werktijden, in overleg.
• Persoonlijk opleidingsbudget van €2.100 elke 3 jaar.
• Bijdrage aan reiskosten vanaf de eerste kilometer.
• Goede bereikbaarheid met het openbaar vervoer, met privéparkeermogelijkheden beschikbaar.
• Pensioenregeling bij Zorg & Welzijn.

Your Role
As a Master Data Specialist, you will play a pivotal role in ensuring the integrity and accuracy of our data management systems. You will oversee data change requests, manage data configuration, and act as the guardian of data quality within our production and supply chain processes.

Key Responsibilities

• Data Integrity: Ensure all master data changes meet quality standards and align with operational requirements.
• Change Management: Evaluate, design, build, and implement data change requests in collaboration with stakeholders.
• Training & Communication: Develop training materials and conduct workshops to ensure smooth adoption of master data updates across teams.
• Cross-Functional Collaboration: Work closely with Commercial Operations, Global Procurement, Quality Control, and other stakeholders to align data strategies with business goals.
• Performance Monitoring: Conduct post-implementation reviews to continuously improve processes and ensure data efficiency.

Your Expertise

• Proven experience in master data management, preferably within the pharmaceutical or life sciences industry.
• Strong understanding of SAP
• Excellent analytical skills and attention to detail.
• Ability to collaborate across multiple departments and navigate complex change processes.
• Strong communication and training skills to effectively convey data updates and requirements.

What We Offer

• A dynamic workplace where innovation meets precision.
• Opportunities for professional growth within the pharmaceutical industry.
• A supportive team dedicated to advancing life sciences.
• Competitive salary and benefits aligned with your expertise.

Our Mission
At Prothya Biosolutions, we’re dedicated to improving lives through innovative solutions in plasma-derived therapies. Join us in our mission to deliver excellence in healthcare.

Apply Today!
Be a part of a team where your attention to detail and passion for quality makes a real difference.

Job Description: As a QA Systems Officer, you will play a crucial role in ensuring the integrity and compliance of our quality management systems. You will be responsible for risk management, overseeing DocuSign processes, and conducting regulatory surveillance to ensure adherence to industry standards and regulations.

Key Responsibilities:

• Develop and implement risk management strategies to identify, assess, and mitigate potential risks.
• Manage and oversee DocuSign processes to ensure secure and compliant electronic signatures.
• Conduct regulatory surveillance to stay updated on relevant laws, regulations, and industry standards.
• Collaborate with cross-functional teams to ensure quality and compliance in all processes.
• Prepare and maintain documentation related to quality management systems.
• Conduct internal audits and support external audits as needed.
• Provide training and guidance to staff on quality and compliance matters.

Qualifications:

• Bachelor’s degree in a relevant field (e.g., Quality Assurance, Regulatory Affairs, Life Sciences).
• Proven experience in risk management, DocuSign, and regulatory surveillance.
• Strong knowledge of GMP (Good Manufacturing Practices) and other relevant regulations.
• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Dutch language is a plus
• Detail-oriented with a commitment to quality and accuracy.

What We Offer:

• A full-time position with a competitive salary.
• A 16.66% budget (holiday allowance and year-end bonus) of your gross salary, which can be used monthly.
• Flexible working hours, subject to agreement.
• Personal training budget of €2,100 every 3 years.
• Contribution to travel expenses from the first kilometer.
• Good accessibility by public transport, with private parking options available.
• Pension plan with Zorg & Welzijn.

Key Responsibilities:

CSV Management and Validation Procedures:

• Develop and maintain CSV policies, procedures, and documentation.
• Manage sub-elements of the Quality System Framework, specifically QSE 4.6 and QSE 6.1.
• Ensure compliance with regulatory requirements and industry best practices.

CSV Expertise:

• Share knowledge and provide training on CSV methods, processes, and systems.
• Serve as a point of contact for customers and during inspections and audits.
• Establish and manage CSV methods, processes, and systems.
• Stay current with regulatory updates and industry standards.

CSV Audits:

• Communicate with auditors during computerized system audits.
• Present validation documentation and evidence to auditors.
• Develop and implement corrective actions in response to audit findings.
• Update CSV policies, procedures, and documentation post-audit.

Compliance:

• Conduct assessments of computer systems, software applications, and processes.
• Collaborate with cross-functional teams to create and maintain validation documentation.
• Perform regular reviews and audits to ensure ongoing compliance.

CSV Projects and Changes:

• Design and implement comprehensive test strategies.
• Coordinate validation efforts with various departments.
• Execute and document validation activities (IQ, OQ, PQ).
• Provide technical guidance and support to project teams.

Qualifications:

• Academic Master’s degree.
• At least 5 years of experience in IT, automation, or QC computerized systems.
• Strong understanding of computer systems, software applications, and validation processes.
• Knowledge of GAMP5, 21 CFR Part 11, and EudraLex Volume 4 Annex 11.
• Experience in developing and executing validation test plans, test scripts, and test cases.
• Excellent problem-solving, analytical, and risk-assessment skills.
• Experience within a GMP production environment.
• Fluency in written and spoken English; Dutch language skills are a plus.

Skills:

• Critical evaluation and interpretation of data.
• Strong knowledge of pharmaceutical manufacturing processes and quality systems.
• Commitment to staying current with industry trends and regulatory updates.
• Social skills such as tact, listening, service attitude, and persuasiveness.
• Ability to create and review validation documentation.
• Systematic and orderly work approach.
• Integrity and representative appearance.

Additional Information:

• Psychological stress can occur in case of calamities and by performing work under time pressure.
• Influence on the quality and efficiency of computerized systems.
• Oral and written expression skills are required for various contacts and documentation.

Our Offer:

• A full-time position with a competitive salary.
• A budget of 16.66% (holiday allowance and year-end bonus) of your gross salary, which can be used monthly.
• Flexible working hours, in consultation.
• Personal training budget of €2,100 every 3 years.
• Contribution to travel expenses from the first kilometer.
• Good accessibility by public transport, with private parking available.
• Pension scheme with Zorg & Welzijn.

Your daily tasks will include:

• Identifying possible improvements and implementing changes
• Leading quality investigations for products and/or services within production
• Ensuring compliance with (GxP) guidelines
• Conducting internal quality controls and inspections on processes, activities, and/or services
• Processing data and findings from inspections, investigations, and validations into insightful reports for (senior) management

Where You Will Work:

• Prothya Biosolutions is one of the few end-to-end pharmaceutical companies in the Netherlands. Our production process goes through all stages from raw material to finished, filled, and packaged product. The production process meets the highest standards as outlined in GMP. Quality and safety are regularly inspected by both Dutch and international authorities.

Your Profile:

• A bachelor’s level education in a scientific field and knowledge of quality in pharmaceutical production processes
• Work experience in the pharmaceutical industry
• Knowledge of GxP guidelines and relevant software systems
• Experience with automation and/or engineering in a production environment a plus
• Strong analytical skills and excellent communication abilities
• Enjoy working in a matrix organization
• Interested in developments within your field and eager to advise on their applicability to production
• Proficiency in English, both written and spoken

What We Offer:

• A full-time position with a competitive salary.
• A budget of 16.66% (holiday allowance and year-end bonus) of your gross salary, which can be used monthly.
• Flexible working hours, subject to agreement.
• Personal training budget of €2,100 every 3 years.
• Contribution to travel expenses from the first kilometer.
• Good accessibility by public transport, with private parking options available.
• Pension plan with Zorg & Welzijn.

The Role:

As the Manager Asset  Engineering, you will be leading a team of approximately 10 seasoned professionals. This is a leadership position where you’ll need to assess the strengths within the team, restructure where needed, and ensure that facilities and assets are maintained to the highest standard. You will be responsible for aligning your team with the company’s goals and driving both internal and external collaborations with suppliers and other campus users.

Key Responsibilities:

• Lead and manage a team of around 10 employees, with a focus on prioritising tasks and unlocking their potential.
• Assess and restructure the current team, identifying areas for talent development and adjusting roles where necessary.
• Provide leadership by creating a structured and clear framework that guides the team towards success.
• Work closely with external partners, including suppliers and other campus users, to ensure seamless operations.
• Engage in strategic conversations and represent your team effectively in tactical discussions regarding the campus.
• Handle a complex budget and ensure that financial decisions are well justified and aligned with company expectations.

What You’ll Bring:

• A team player who enjoys leading and guiding teams toward their best performance.
• Proactive and entrepreneurial, with a strong sense of urgency and an ability to navigate through challenges with minimal internal support.
• Strong in communication, both with your internal team and external stakeholders, ensuring smooth collaboration on all levels.
• Adaptable and strategic, with a talent for spotting inefficiencies and proposing effective solutions.

Your Background:

• Education: Technical college education or equivalent, ideally with knowledge of facility management or asset engineering.
• Experience: At least 5 years of relevant experience, including time spent in management roles, preferably in a pharmaceutical or healthcare setting.
• Skills: Ability to lead, communicate effectively, and manage both people and processes in a dynamic, high-stakes environment.

What do we offer you?

• Team: You will work in a dynamic, diverse, and close-knit team.
• Attractive Salary: Up to €8,000 per month, with an 8.33% year-end bonus and an 8.33% holiday allowance.
• Generous Time Off: 30 vacation days, some of which can be flexibly used in exchange for the purchase of a bicycle, training, or paid out, etc.
• Development: A training budget of €2,100 every 3 years to deepen your knowledge.
• Travel Allowance: From the first kilometre (€0.23 per km, max. 30 km).
• Pension Plan: A solid pension scheme through PFZW.

Why Prothya Biosolutions?

At Prothya Biosolutions, you will be part of an innovative team that values leadership, collaboration, and continuous improvement. You will play a key role in ensuring that our facilities are safe, efficient, and optimised for production, all while contributing to the delivery of critical healthcare products.

Join us and help us continue our mission of Creating Value, Sustaining Life.

Apply today to become a key player in our team and help shape the future of facility engineering at Prothya.

Key Responsibilities

Quality Assurance & Oversight:

• Monitor compliance with GMP regulations and internal policies, focusing on Quality Oversight of suppliers and customers.
• Act as a key QA contact for suppliers and customers, driving quality initiatives and resolving issues.
• Manage quality contracts with external partners, oversee supplier complaints, and lead qualification and performance assessments.
• Ensure timely responses to audit findings and provide regular management reports.

Auditing:

• Plan and execute internal and external audits for Prothya’s suppliers, customers, and service providers, both locally and internationally.
• Lead GMP audits, coordinating cross-functional teams and providing guidance during audits.
• Prepare for and facilitate external audits at Prothya, including documentation management and follow-up on previous findings.

Continuous Improvement & Compliance:

• Keep up to date with industry trends, regulatory changes, and best practices in GMP and Quality Oversight.
• Identify risks and opportunities for improvement, ensuring Prothya remains compliant and competitive.
• Draft and assess audit reports, ensuring alignment with Prothya’s Quality Management System (QMS).

Collaboration & Communication:

• Collaborate with internal teams, including Procurement, Regulatory Affairs, and Quality Assurance, to align on quality objectives.
• Maintain open communication with stakeholders, providing updates on quality activities and sharing actionable insights.

What We’re Looking For

• HBO-level education in a relevant field such as pharmaceutical sciences or quality management.
• Certified Lead Auditor credentials are a must.
• At least 5 years of experience in a similar role, ideally within a cGMP environment.
• Previous experience in the pharmaceutical sector is highly desirable.
• In-depth knowledge of audit methods, pharmaceutical regulations, and quality systems.
• Strong organisational skills with a keen eye for detail.
• Excellent communication and interpersonal skills to work effectively across teams and stakeholders.
• A proactive, solutions-oriented mindset with a passion for maintaining the highest standards of quality.

Why Join Prothya Biosolutions?

• Make a meaningful impact on patients’ lives by contributing to life-saving therapies.
• Be part of a company that values collaboration, innovation, and excellence.
• Access opportunities for professional growth and continuous learning.
• Work in a culture that prioritises quality and compliance as core values.
• Competitive compensation and benefits package.

Ready to Join the Prothya Team?
We’re looking for talented individuals who share our dedication to improving patient outcomes. Let’s shape the future of healthcare together.

Key Responsibilities:

• Account Planning & Management: Craft and execute comprehensive account plans to meet and exceed sales targets.
• Client Relationship Building: Maintain and expand relationships with a wide network of clients, including procurement officers, pharmacists, nurse specialists and medical specialists, ensuring long-term engagement and trust.
• Customer Service Excellence: Act as the primary point of contact for your accounts, addressing client needs and managing expectations with a proactive, solutions-driven approach.
• Problem Solving & Damage Control: Navigate challenges such as product shortages and operational issues with resilience, keeping clients informed and reassured through transparent communication.
• Product Promotion: Advocate for existing and newly developed products, despite limited marketing resources, and find creative ways to engage clients.
• Strategic Collaboration: Work closely with internal departments to stay informed on product availability (this is primarly done by me) and company policies, ensuring seamless operations and client satisfaction.

Qualifications & Skills:

• Experience: Minimum of 5 years in a senior account management role, preferably in the pharmaceutical or biopharmaceutical sectors.
• Education: A Bachelor’s degree in a relevant field. Advanced education is a plus.
• Communication: Fluent in Dutch and English. French would be a benefit
• Resilience: Strong ability to handle high-stress situations and manage complex client relationships with tact and professionalism.
• Proactivity: A proactive mindset for client follow-up and relationship maintenance, even during operational difficulties.

What We Offer:

• A competitive salary ranging from €4,379.34 to €6,295.23, aligned with your expertise and experience.
• 8.33% end-of-year bonus and holiday allowance.
• Flexible working hours with full-time employment. (home-based)
• Access to €2,100 in training funds every three years for your professional development.
• Comprehensive pension plan through Zorg & Welzijn.
• Travel reimbursement starting from the first kilometre. Company car
• The opportunity to work in a collaborative, innovative environment where your contributions help ensure the health and well-being of countless individuals.

If you are an experienced account manager ready to embrace a challenging yet rewarding role within a dynamic team, we invite you to apply. Your expertise and commitment can help shape the future of healthcare solutions at Prothya Biosolutions