QA Validation Lead - GMP Compliance & Process Validation

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

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