QA Validation Manager

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

The QA Validation Manager is responsible for ensuring all critical GMP processes are validated and maintained in compliance with product requirements, process parameters, and global regulatory guidelines. The role works closely with MSAT, Manufacturing, and clients to provide scientifically sound, documented evidence that processes will perform as required, assuring sustainable product quality. The position serves as a key QA point of contact for validation projects, product transfers, and validation strategy, while supporting compliance throughout the product lifecycle.

Key Accountabilities

• Ensure critical GMP processes are validated and maintained in compliance with product requirements, process parameters, and global regulatory guidelines.
• Collaborate closely with MSAT, Manufacturing, and clients to ensure processes are supported by scientifically sound and documented evidence.
• Maintain oversight of 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 continuous process verification (CPV) and process validation activities.
• Act as a key QA point of contact for product transfer activities and related validation strategies.
• Prioritize and manage workload in alignment with line manager requirements and site goals.
• Perform change control and deviation impact assessments.
• Support investigations of non-conformities.
• Demonstrate understanding of cell and gene manufacturing processes, equipment, product control strategies, and low bioburden environmental assurance.
• Provide technical expertise in the review and approval of SOPs, protocols, reports, change controls, deviations, and other GMP records for QA closure.
• Participate in audits and inspections to demonstrate compliance with European and U.S. FDA regulations.
• Serve as the subject matter expert (SME) for SOPs related to Process Validation and Cleaning Validation.
• Review and approve validation documentation, including Process Validation, Cleaning Validation, and Computer System Validation (CSV) documentation.
• Participate in risk assessments.
• Support the Data Integrity Program.

Qualifications

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