Biopharma QA Specialist (QMS & Compliance)

agap2 Switzerland; Basel; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

agap2 Switzerland seeks a Quality Assurance consultant to join our Basel-area team. You will maintain the QMS, prepare batch release documentation, and draft GMP-related and validation materials for biotech projects.

You hold a PharmD, engineering, biotechnology, or quality management degree and bring GMP knowledge, plus fluency in English and German in an international setting. On-site collaboration with clients is essential.

Qualifikationen

• Requires strong knowledge of QMS and GMP-based quality systems.
• Experience in biotechnology or biopharmaceutical manufacturing.
• Fluency in English and German, written and spoken.

Aufgaben

• Maintain the Quality Management System (QMS) and ensure continuous improvement.
• Prepare batch release documentation and review batch records.
• Draft, review, and approve GMP-related documentation.
• Review biotechnology process validation documentation (validation plans, protocols, reports).
• Manage quality events and systems such as Change Controls, Deviations, CAPA, OOS investigations, and complaints.
• Oversee quality activities related to 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.

Kenntnisse

Quality management

Regulatory compliance

Biotech manufacturing

GMP / cGMP

Cross-functional work

English & German

Ausbildung

PharmD

Engineering

Biotechnology

Quality Management

Jobbeschreibung

agap2 Switzerland seeks a Quality Assurance consultant to join our Basel-area team. You will maintain the QMS, prepare batch release documentation, and draft GMP-related and validation materials for biotech projects.

You hold a PharmD, engineering, biotechnology, or quality management degree and bring GMP knowledge, plus fluency in English and German in an international setting. On-site collaboration with clients is essential.