Quality Assurance Specialist

About the role

agap2 is seeking a Quality Assurance Specialist to support its clients in the biotechnology and biopharmaceutical sectors. The role involves on‑site work to ensure compliance with regulatory standards and to drive continuous improvement of quality systems across complex projects.

Key responsibilities

• Maintain and continuously improve the Quality Management System (QMS).
• Prepare and review batch release documentation and detailed batch records.
• Draft, review, and approve GMP‑related documents and biotechnology process validation files (plans, protocols, reports).
• Manage quality events such as Change Controls, Deviations, CAPA, OOS investigations, and customer complaints.
• Oversee quality activities for subcontractors and CMOs, including qualification and performance monitoring.
• Develop, update, and maintain quality procedures and SOPs.
• Prepare Annual Product Quality Reviews (APQRs) and conduct internal audits.
• Support regulatory inspections and provide necessary documentation.

Required profile

• Degree in Pharmacy (PharmD), 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.
• Ability to work in an international, cross‑functional environment.
• Fluency in written and spoken English and German.

Required skills

• cGMP compliance
• Quality Management System (QMS) operation
• Process validation (plans, protocols, reports)
• USP, DSP, Fill & Finish operations
• Change Control management
• CAPA and OOS investigation handling