Quality Assurance Engineer - Biotechnology

About the role

agap2 is a European engineering and operational consulting group founded in 2005, active in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals and Information Technology sectors. As a consultant, you will support its clients on site in the realization of their projects, adapting quickly to different work environments and gaining insight into the projects behind the scenes.

Key responsibilities

• Maintain and continuously improve the Quality Management System (QMS)
• Prepare batch release documentation, including a detailed review of batch records
• Draft, review and approve GMP-related documentation
• Review and approve biotechnology process validation documentation (plans, protocols and reports)
• Manage quality events and systems 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)
• Conduct internal audits and support regulatory inspections

Required profile

• Degree in Pharmacy (PharmD), Engineering, Biotechnology or Quality Management
• Prior experience in the biotechnology or biopharmaceutical industry
• Fluency in written and spoken English and German is mandatory
• Comfortable working in an international and cross-functional environment

Required skills

• Understanding of biotechnological manufacturing processes, including USP, DSP and Fill & Finish operations
• Good knowledge of cGMP regulations and quality standards