Quality Assurance Engineer

About the role

agap2 is seeking a Quality Assurance Engineer to support our clients on‑site across the biotech and biopharmaceutical sectors. You will ensure the robustness of quality systems while contributing to high‑impact projects.

Key responsibilities

• Maintain and continuously improve the Quality Management System (QMS).
• Prepare batch release documentation and review batch records.
• Draft, review, and approve GMP‑related documents.
• Validate biotechnology processes, including validation plans, protocols, and reports.
• Manage quality events such as Change Controls, Deviations, CAPA, OOS investigations, and customer complaints.
• Oversee subcontractor and CMO quality activities, including qualification and performance monitoring.
• Develop and update quality procedures, SOPs, and Annual Product Quality Reviews (APQRs).
• Conduct internal audits and support regulatory inspections.

Required profile

• Degree in Pharmacy, Engineering, Biotechnology, or Quality Management.
• Prior experience in the biotechnology or biopharmaceutical industry.
• Strong understanding of biotechnological manufacturing processes (USP, DSP, Fill & Finish).
• Good knowledge of cGMP regulations and quality standards.
• Fluent in English and German, both written and spoken.

Required skills

• cGMP compliance
• USP manufacturing
• DSP manufacturing
• Fill & Finish operations