GMP QA Specialist: Drive Compliance & Quality Manufacturing

Biosynth; Lelystad; On-site; EUR 50,000 - 70,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

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

Skills

GMP compliance

QA/QC processes

Deviation management

Analytical methods

Organizational skills

Tools

eQMS

eDMS

Job description

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.