QA Engineer — Biotech & GMP Compliance Specialist

agap2 Switzerland; Basel; On-site; CHF 95,000 - 130,000; Full time

Job summary

agap2 Switzerland is seeking a quality-focused consultant to support biotech and biopharmaceutical clients on site in Basel. You will bring expertise in QMS, GMP, and regulatory standards to ensure compliant manufacturing and release processes.

The role requires collaboration across cross-functional teams in an international environment, fluency in English and German, and a proactive approach to audits, CAPA, and continuous improvement.

Qualifications

• Degree in Pharmacy (PharmD), Engineering, Biotechnology, or Quality Management.
• Experience in biotechnology or biopharmaceutical industry.
• Knowledge of cGMP regulations and quality standards.

Responsibilities

• Maintain and improve the Quality Management System (QMS).
• Prepare batch release documentation and review batch records.
• Draft, review, and approve GMP documentation.
• Review biotechnology process validation docs (plans, protocols, reports).
• Manage quality events: CAPA, deviations, OOS, complaints.
• Oversee subcontractors and CMOs quality activities.
• Develop and maintain quality procedures and SOPs.
• Prepare APQRs (Annual Product Quality Reviews).
• Conduct internal audits and support regulatory inspections.

Skills

Quality systems knowledge

Regulatory compliance

Biotechnology manufacturing

GMP knowledge

Cross-functional collaboration

English & German fluency

Education

PharmD / Degree in Pharmacy

Biotechnology degree

Quality management degree

Job description

agap2 Switzerland is seeking a quality-focused consultant to support biotech and biopharmaceutical clients on site in Basel. You will bring expertise in QMS, GMP, and regulatory standards to ensure compliant manufacturing and release processes.

The role requires collaboration across cross-functional teams in an international environment, fluency in English and German, and a proactive approach to audits, CAPA, and continuous improvement.