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Quality Assurance Specialist

Biosynth -
Lelystad

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Vacaturegegevens

Kwalificaties

Analytisch vermogen
Kwaliteitsborging
APIs

Volledige vacaturetekst

We take great pride in our vast range of chemical and biochemical products and our high standards can only be maintained through great people who share our values and desire to do the very best job possible every day.

We acknowledge the important part our team members, who are based over three continents with manufacturing laboratories and distribution centres in Switzerland, Austria, the Netherlands, the United Kingdom, Ireland, Germany Slovakia, China, and the United States play in our continued success.

Main Purpose of the Job

We are seeking a proactive and detail-oriented QA Specialist to join our Quality team. This is a hands-on role with strong interaction on the production floor and direct involvement in daily GMP operations. You will act as a key QA business partner to manufacturing, ensuring compliance, driving quality improvements, and supporting the delivery of high-quality products in a regulated environment.

Key Responsibilities

Own and maintain the GMP Quality Management System in line with ICH Q7 and EudraLex Volume 4 Part II
Act as QA business partner to production, ensuring GMP compliance in daily operations
Lead and manage deviations, CAPAs, and change controls, including investigations, root cause analysis, and effectiveness checks
Perform batch record review and provide QA oversight for manufacturing and analytical activities
Provide QA oversight and approval of equipment qualification and process validation activities
Drive continuous improvement initiatives using a risk-based approach (e.g. ICH Q9)
Lead and perform internal audits, supplier audits, and support customer audits
Support and host regulatory and client inspections
Ensure an effective training system, maintaining compliance and qualification of GMP personnel
Review and approve technical documentation, including manufacturing instructions, analytical methods, and validation protocols/reports
Monitor and trend quality data (deviations, CAPAs, complaints) and translate insights into actionable improvements
Work within a contract manufacturing (CMO) environment, ensuring alignment with client requirements and quality agreements
Support supplier qualification and oversight of external service providers
Work with electronic quality systems (e.g. eQMS, eDMS, training systems)

Candidate Requirements

Minimum 3 years of experience in QA within a GMP-regulated environment
Strong knowledge of API / Drug Substance manufacturing processes
Solid understanding of QA/QC processes and regulatory expectations
Proven experience managing deviations, CAPAs, and change controls
Experience within a contract manufacturing environment is a strong advantage
Familiarity with Regulatory Affairs interactions is preferred
Experience with electronic quality systems (eQMS, eDMS)
Knowledge of process validation is desirable
Strong attention to detail with excellent organisational and multitasking abilities
Results-oriented mindset with a proactive, solution-focused approach
Collaborative team player with experience working cross-functionally

About Us

Biosynth® is an innovative life sciences reagents, custom synthesis and manufacturing services company headquartered in Staad, Switzerland. We are by scientists, for scientists, securing supply chains with consistent quality, across the globe. As a trusted supplier, manufacturer and partner to the pharmaceutical, life science and diagnostic industries, as well as food, agrochemical and cosmetic customers, we have facilities on three continents and a rapid global distribution network. Our main production laboratories are located in Switzerland, the UK, Slovakia and China, with peptide and antibody production in the US, the UK and the Netherlands. Enzyme projects are based in Austria, bioconjugation projects in Germany and biological IVD reagents in Ireland.

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specialist vacatures in flevoland

Quality Assurance Specialist

Junior SEO Specialist

Vaktechnisch specialist pootgoed

Documentation Specialist / AI SaaS

Product Data Specialist

Procurement Specialist

Master Data Management Specialist

SEA Specialist

HSE Specialist

Specialist Instructor (LNG)

Supply Chain Specialist

Supply Chain Specialist

Online Content Specialist (Digital Shelf Operations) - Amsterdam area/ Almere / Hybrid

Bi Specialist

Medior/Senior SEO Specialist

Specialisten

Short-term Trader/Forecasting Specialist Audax Energy Trade

Orderdesk Specialist

Business Operations Specialist

Senior PPC Specialist

Ik wil de nieuwste vacature-alerts ontvangen voor de functie van specialist in flevoland

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