Biotech QA Consultant - GMP, QMS & Audits

agap2 Switzerland; Basel; Vor Ort; CHF 100.000 - 140.000; Vollzeit

Zusammenfassung

agap2 Switzerland seeks a consultant to support clients on site, contributing extensive expertise to maintain QMS and ensure GMP-compliant batch release documentation. The role involves drafting and approving GMP docs, reviewing validation activities, and managing CAPA, OOS investigations, and subcontractor quality activities.

The successful candidate will have a degree in PharmD, engineering, biotechnology, or quality management, plus biotech industry experience and fluency in English and

Qualifikationen

• Degree in Pharmacy (PharmD), Engineering, Biotechnology or Quality Management
• Experience in biotech or biopharmaceutical industry
• Understanding of biotechnological manufacturing processes including USP, DSP and Fill & Finish
• Good knowledge of cGMP regulations and quality standards
• Comfortable working in an international and cross-functional environment
• Fluency in English and German (written and spoken) 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 performance monitoring
• Develop, update, and maintain quality procedures and SOPs
• Prepare Annual Product Quality Reviews (APQRs)
• Conduct internal audits and provide support during regulatory inspections

Kenntnisse

Biotech manufacturing knowledge

GMP knowledge

Cross-functional environment

English & German proficiency

Ausbildung

PharmD

Engineering

Biotechnology

Quality Management

Jobbeschreibung

agap2 Switzerland seeks a consultant to support clients on site, contributing extensive expertise to maintain QMS and ensure GMP-compliant batch release documentation. The role involves drafting and approving GMP docs, reviewing validation activities, and managing CAPA, OOS investigations, and subcontractor quality activities.

The successful candidate will have a degree in PharmD, engineering, biotechnology, or quality management, plus biotech industry experience and fluency in English and