Quality Assurance Specialist

Biosynth; Lelystad; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A life sciences company in Lelystad is seeking a proactive QA Specialist to join its Quality team. This hands-on role involves ensuring GMP compliance, managing deviations, CAPAs, and conducting internal audits. The ideal candidate has at least 3 years of QA experience in a regulated environment and a strong knowledge of API manufacturing processes. The company offers a collaborative environment where you will directly influence quality outcomes and support product delivery with stringent quality standards.

Formación

• Minimum 3 years of experience in QA within a GMP‑regulated environment.
• Strong knowledge of API / Drug Substance manufacturing processes.
• Proven experience managing deviations, CAPAs, and change controls.

Responsabilidades

• Own and maintain the GMP Quality Management System.
• Lead and manage deviations, CAPAs, and change controls.
• Perform batch record review for manufacturing activities.

Conocimientos

GMP compliance

QA/QC processes

Deviation management

Analytical methods

Organizational skills

Herramientas

eQMS

eDMS

Descripción del empleo

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.

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.