Overview
Quality Assurance Specialist Jobs in Lelystad, Flevoland, Netherlands at Biosynth
Title: Quality Assurance Specialist
Company: Biosynth
Location: Lelystad, Flevoland, Netherlands
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.
Recruitment agencies – we are unable to accept unsolicited CVs and communications from external recruiters. We do not engage with recruitment agencies to recruit for our roles.
