QA Validation Manager

Proclinical Staffing; Oberwallis; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Proclinical Staffing is seeking a QA Validation Manager to oversee and ensure compliance of critical GMP processes with product requirements and regulatory guidelines. You will collaborate with Manufacturing and clients to provide scientifically sound evidence supporting product quality throughout the lifecycle.

The role requires strong knowledge of process and cleaning validation, equipment qualification, and change control, with hands-on involvement in audits and inspections under EU and US

Qualifikationen

• Degree in Science, Biotechnology, or related field.
• Strong knowledge of process validation and cleaning validation; qualification of equipment.
• Experience with change controls, deviations, and non-conformity investigations.
• Understanding of cell and gene manufacturing processes and low bioburden environments.
• Fluent English; German a plus.

Aufgaben

• Validate GMP processes and ensure compliance with regulatory guidelines.
• Oversee validation activities for biotech manufacturing in low bioburden environments.
• Lead CPV and process validation activities.
• Review SOPs, protocols, reports, change controls, and deviations.
• Participate in audits and inspections to meet EU/US FDA standards.
• Support continuous improvement and Data Integrity initiatives.

Kenntnisse

Process validation

Cleaning validation

Equipment qualification

Change control

Deviation management

Non-conformity investigations

CPV/Process validation

Ausbildung

B.S. in Science/Biotechnology

Tools

CSV

Jobbeschreibung

Join our client and play a key role in maintaining top-tier quality standards! If you have a keen eye for detail and a passion for compliance, this could be your perfect opportunity.

Proclinical is seeking a QA Validation Manager to oversee and ensure compliance of critical GMP processes with product requirements, process parameters, and global regulatory guidelines. This role involves close collaboration with cross-functional teams, Manufacturing, and clients, to provide scientifically sound evidence supporting sustainable product quality. You will act as a key QA point of contact for validation projects, product transfers, and validation strategies while supporting compliance throughout the product lifecycle.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities

• Ensure critical GMP processes are validated and maintained in compliance with regulatory guidelines and product requirements.
• Oversee validation activities for biotechnological manufacturing processes in low bioburden environments.
• Support validation of manual and automated cleaning and sanitization processes.
• Manage qualification requirements for related equipment and systems.
• Lead continuous process verification (CPV) and process validation activities.
• Act as a QA point of contact for product transfer activities and validation strategies.
• Perform change control and deviation impact assessments.
• Support investigations of non-conformities and ensure resolution.
• Review and approve SOPs, protocols, reports, change controls, deviations, and other GMP records.
• Participate in audits and inspections to demonstrate compliance with European and US FDA regulations.
• Contribute to continuous improvement initiatives.
• Serve as a subject matter expert (SME) for Process Validation and Cleaning Validation SOPs.
• Review and approve validation documentation, including Process Validation, Cleaning Validation, and Computer System Validation (CSV).
• Participate in risk assessments and support the Data Integrity Program.

Key Skills and Requirements

• Degree in Science, Biotechnology, or a related field.
• 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 language skills are a plus.