QA Validation Lead - Biotech GMP, Onsite in Valais

Recrutis; Wallis; Vor Ort; CHF 110.000 - 170.000; Vollzeit

Zusammenfassung

Recrutis is supporting a leading biopharmaceutical manufacturing site in Switzerland in search of a QA Validation Manager based in the canton of Valais. The role offers full QA ownership of validation for critical GMP processes and acts as the QA point of contact for validation projects and product transfers.

With 5 to 7 years of pharmaceutical GMP experience, you will oversee manual and automated cleaning validation, review SOPs and reports, and participate in audits and inspections.

Qualifikationen

• Bachelor's degree in science, biotechnology or a related field.
• 5 to 7 years of pharmaceutical industry experience in a GMP-regulated environment.
• Strong knowledge of process validation, cleaning validation, and equipment and system qualification.

Aufgaben

• Ensure critical GMP processes are validated and maintained in compliance with product requirements, process parameters and global regulatory guidelines.
• Oversee validation activities for biotechnological manufacturing processes in a low bioburden environment.
• Support validation of manual and automated cleaning and sanitisation processes, and oversee qualification requirements for related equipment and systems.
• Manage CPV and process validation activities.
• Act as key QA contact for product transfer activities and the associated validation strategy.
• Perform change control and deviation impact assessments, and support non-conformity investigations.
• Review and approve SOPs, protocols, reports, change controls, deviations and other GMP records for QA closure, including Process Validation, Cleaning Validation and CSV documentation.
• Participate in risk assessments, audits and inspections, and support the Data Integrity Program and continuous improvement initiatives.

Kenntnisse

Process validation

Cleaning validation

Quality Assurance

Change controls

Deviation management

Non-conformity investigations

Validation documentation review

Ausbildung

Bachelor's degree in science/ biotechnology or related field

Jobbeschreibung

Recrutis is supporting a leading biopharmaceutical manufacturing site in Switzerland in search of a QA Validation Manager based in the canton of Valais. The role offers full QA ownership of validation for critical GMP processes and acts as the QA point of contact for validation projects and product transfers.

With 5 to 7 years of pharmaceutical GMP experience, you will oversee manual and automated cleaning validation, review SOPs and reports, and participate in audits and inspections.