Quality Assurance Specialist

About the role

agap2 is seeking a Quality Assurance Specialist to support its clients in the biotechnology and biopharmaceutical sectors. You will work on‑site, ensuring that quality systems meet the highest standards while contributing to the success of large‑scale 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.
• Manage process validation documentation, including plans, protocols, and reports.
• Handle quality events such as Change Controls, Deviations, CAPA, OOS investigations, and customer complaints.
• Oversee subcontractor and CMO qualification, performance monitoring, and related quality activities.
• 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.
• Fluency in English and German (written and spoken).

Required skills

• cGMP
• USP
• DSP
• Fill & Finish operations
• Process validation
• Batch release documentation

What we offer

• Opportunity to work on high‑impact projects across multiple industries.
• International, cross‑functional team environment.
• Professional development in a leading engineering and consulting group.