QA Validation Manager: GMP Biotech Process Excellence

Gi Group; Oberwallis; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Gi Group is seeking a QA Validation Manager to ensure critical GMP processes are validated and maintained in accordance with product requirements, process parameters, and global regulatory guidelines. The role partners with MSAT, Manufacturing and clients to provide scientifically sound, documented evidence that processes perform as required.

The candidate will oversee CPV and validation activities, manage change controls and deviations, and serve as QA SME for validation documentation and

Qualifikationen

• Bachelor's degree in Science, Biotechnology, or related field.
• 5-7 years of experience in the pharma industry within GMP environment.
• Strong knowledge of process validation, cleaning validation, and qualification of equipment/systems.
• Experience with change controls, deviation management, and investigations of non-conformities.
• Understanding of cell and gene manufacturing processes and low bioburden environments.
• Proficiency in English; German is a plus.

Aufgaben

• Validate GMP processes and maintain compliance with product requirements and global guidelines.
• Collaborate with MSAT, Manufacturing, and clients to provide scientifically sound evidence.
• Oversee validation activities for biotechnological manufacturing processes in a low bioburden environment.
• Support validation of manual and automated cleaning and sanitization processes.
• Oversee qualification requirements of related equipment and systems.
• Manage CPV and process validation activities.
• Act as QA contact for product transfer activities and validation strategies.
• Provide QA review of SOPs, protocols, and reports for closure.

Kenntnisse

Process validation

Cleaning validation

Equipment qualification

Change controls

Deviation management

Non-conformity investigations

Cell and gene manufacturing

English proficiency

German language

Ausbildung

Bachelor's degree in Science/ Biotechnology

Jobbeschreibung

Gi Group is seeking a QA Validation Manager to ensure critical GMP processes are validated and maintained in accordance with product requirements, process parameters, and global regulatory guidelines. The role partners with MSAT, Manufacturing and clients to provide scientifically sound, documented evidence that processes perform as required.

The candidate will oversee CPV and validation activities, manage change controls and deviations, and serve as QA SME for validation documentation and