QA Validation Lead – GMP, Process & Cleaning Validation

Proclinical Group; Oberwallis; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Proclinical Group is recruiting a QA Validation Manager in Switzerland to oversee GMP validation for critical processes and regulatory alignment. You will partner with Manufacturing and clients to ensure robust evidence supports product quality and lifecycle compliance.

The role requires expertise in PV, cleaning validation, equipment qualification, and risk assessments, with English proficiency and German a plus. On-site position in Wallis, Oberwallis region, with potential travel.

Qualifikationen

• Experience with GMP validation and product requirements.
• Experience with change controls, deviations, and non-conformity investigations.
• Knowledge of cell and gene manufacturing processes and low bioburden environments.
• Proficiency in English; German language skills are a plus.

Aufgaben

• 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 CPV and process validation activities.
• Act as QA 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 GMP records.
• Participate in audits and inspections to demonstrate compliance with European and US FDA regulations.
• Contribute to continuous improvement initiatives.
• Serve as SME for Process Validation and Cleaning Validation SOPs.
• Review and approve validation documentation including PV, CV, and CSV.
• Participate in risk assessments and support Data Integrity Program.

Kenntnisse

Process validation

Cleaning validation

Equipment/system qualification

Change controls

Deviation management

Non-conformity investigations

SOPs review/approval

Risk assessments

Data Integrity program

QA liaison

Ausbildung

Bachelor's degree in Science/Biotechnology

Jobbeschreibung

Proclinical Group is recruiting a QA Validation Manager in Switzerland to oversee GMP validation for critical processes and regulatory alignment. You will partner with Manufacturing and clients to ensure robust evidence supports product quality and lifecycle compliance.

The role requires expertise in PV, cleaning validation, equipment qualification, and risk assessments, with English proficiency and German a plus. On-site position in Wallis, Oberwallis region, with potential travel.