On-Site Biotech QA Engineer – GMP & QMS Focus

agap2 Switzerland; Basel; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

agap2 Switzerland is seeking a quality-focused consultant to support on-site projects in biotech and biopharmaceutical environments. You will help maintain QMS, draft GMP documentation, and review validation activities as part of cross-functional teams.

The ideal candidate holds a PharmD, engineering, biotech, or QA degree, has experience in biotech manufacturing, understands USP, DSP, and CGMP, and is fluent in English and German to work in international settings.

Qualifikationen

• Degree in Pharmacy (PharmD) or Engineering, Biotechnology, or Quality Management.
• Prior experience in biotechnology or biopharmaceutical industry.
• Strong understanding of biotechnological manufacturing processes (USP, DSP, Fill & Finish).
• Good knowledge of cGMP regulations and quality standards.
• Comfortable working in an international, cross-functional environment.
• Fluency in English and German, both written and spoken, is mandatory.

Aufgaben

• Ensure the maintenance and continuous improvement of the Quality Management System (QMS).
• Prepare batch release documentation, including detailed review of batch records.
• Draft, review, and approve GMP-related documentation.
• Review and approve biotechnology process validation documentation (validation plans, protocols, and reports).
• Manage quality events and systems such as Change Controls, Deviations, CAPA, OOS investigations, and customer complaints.
• Oversee quality activities related to subcontractors and CMOs, including qualification and monitoring.
• Develop, update, and maintain quality procedures and SOPs.
• Prepare Annual Product Quality Reviews (APQRs).
• Conduct internal audits and support regulatory inspections.

Kenntnisse

QMS maintenance

GMP documentation

Biotech manufacturing

Cross-functional collaboration

English & German fluency

Ausbildung

PharmD, Engineering, Biotechnology, or Quality Management degree

Jobbeschreibung

agap2 Switzerland is seeking a quality-focused consultant to support on-site projects in biotech and biopharmaceutical environments. You will help maintain QMS, draft GMP documentation, and review validation activities as part of cross-functional teams.

The ideal candidate holds a PharmD, engineering, biotech, or QA degree, has experience in biotech manufacturing, understands USP, DSP, and CGMP, and is fluent in English and German to work in international settings.