QA Project Specialist
QA Project Specialist | Amsterdam | cGMP | Change Control | Validation | Pharmaceutical Manufacturing | 105035
QA Project Specialist
Your new company
Our client is an established biopharmaceutical organisation based in Amsterdam, specialising in the development and production of plasma-derived medicinal products. Their work focuses on transforming donated blood plasma into essential therapies used in areas such as immunology, critical care and rare disease treatment. With a strong scientific heritage and extensive experience in plasma fractionation and protein therapies, the organisation operates in a highly regulated cGMP environment where quality, patient safety and supply reliability are central to daily operations.
Your new company
Our client is an established biopharmaceutical organisation based in Amsterdam, specialising in the development and production of plasma-derived medicinal products. Their work focuses on transforming donated blood plasma into essential therapies used in areas such as immunology, critical care and rare disease treatment. With a strong scientific heritage and extensive experience in plasma fractionation and protein therapies, the organisation operates in a highly regulated cGMP environment where quality, patient safety and supply reliability are central to daily operations.
Your new role
As QA Project Specialist, you will provide Quality Assurance guidance across change control projects within a GMP-regulated production environment. You will act as the QA representative in multidisciplinary project teams and ensure that documentation, systems, processes and reports remain compliant with cGMP regulations, internal quality policies and external requirements.
In this role, you will combine strong project coordination skills with in-depth QA knowledge, helping the organisation implement changes effectively while maintaining the highest quality and compliance standards.
- Represent QA in change control projects within a GMP-regulated production environment.
- Assess the quality impact, compliance risks and validation requirements of proposed changes.
- Ensure change control documentation, reporting and system updates are accurate, complete and inspection-ready.
- Translate quality strategies into practical guidelines, procedures and change control documentation.
- Provide QA advice, training and guidance to internal stakeholders and project teams.
- Act as Subject-Matter Expert during audits, inspections and quality-related stakeholder meetings.
What you'll need to succeed - You are a proactive QA professional with strong analytical, organisational and communication skills.
- A bachelor's or master's degree in a technical, chemical, biotechnological or related discipline.
- At least 3 years of experience in Quality Assurance or quality management within a cGMP environment.
- Strong knowledge of cGMP guidelines, change control and validation processes.
- A structured way of working, with the ability to make well-considered decisions in complex project environments.
- Excellent written and spoken English communication skills; Dutch language skills are considered a strong advantage.
- Experience coordinating projects and working with multidisciplinary teams.
What you'll get in return
- A 6-month contract via Hays, with the possibility of takeover after the initial assignment.
- A salary range starting from €4,700 gross per month, depending on experience.
- 8.33% end-of-year bonus and 8.33% holiday allowance.
- A personal training budget
- Travel expense reimbursement from the first kilometre.
- Excellent accessibility by public transport, with private parking available.
- A pension plan.
What you need to do now
If you're interested in this role, apply now or contact us for more information. If this position is not quite right for you, but you are looking for a new opportunity within Quality Assurance, GMP or Life Sciences, please get in touch for a confidential discussion about your career.
If you're interested in this role, apply now or contact us for more information. If this position is not quite right for you, but you are looking for a new opportunity within Quality Assurance, GMP or Life Sciences, please get in touch for a confidential discussion about your career.
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Overzicht
- Contractvorm
- Tijdelijk
- Branche
- Wetenschap, Research & Development
- Locatie
- Amsterdam
- Vakgebied
- Life Sciences
- Salaris
- Salary beginning from 4700 gross per month, excl.13th month, travel expenses
- Referentie:
- 1050359
Spreek met een consultant
Spreek met Kate Baldwin, de recruiting expert die deze vacature in behandeling heeft, werkzaam in kantoor Amsterdam
Hays Amsterdam, Rijnsburgstraat 9-11
Telefoonnummer: +31202361013
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