Senior CSV QA Expert – GMP/MES Validation (Contract)

CTC Resourcing Solutions; Basel; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

CTC Resourcing Solutions is seeking a Senior QA Expert CSV for a Basel/Stein area contract role in Switzerland. You will provide CSV QA support for major CAPEX projects, ensuring GMP compliance and data integrity throughout the lifecycle.

The role requires English fluency and a strong background in validation documentation, with collaboration across Automation, IT, Manufacturing and Projects. 5.5 months contract with expectation of close regulatory alignment.

Qualifikationen

• Bachelor or Master in Engineering, Life Sciences or related field.
• Significant experience in GMP regulated pharmaceutical industry.
• Fluent in English; German would be an advantage.

Aufgaben

• QA review and approval of validation documentation related to MODA (MES) integration (FRS, IQ, OQ, PQ) and related protocols/reports.
• Assess and approve documentation for Change Management and Deviation/Incident Management.
• Review and approve Automation Change Controls (ACCs) ensuring GMP/data integrity compliance.
• Collaborate with Automation, IT, Manufacturing and Project teams to maintain compliant computerized systems.

Kenntnisse

GMP experience

English fluency

Quality Assurance

Regulatory compliance

Ausbildung

Bachelor or Master in Engineering or Life Sciences

Jobbeschreibung

CTC Resourcing Solutions is seeking a Senior QA Expert CSV for a Basel/Stein area contract role in Switzerland. You will provide CSV QA support for major CAPEX projects, ensuring GMP compliance and data integrity throughout the lifecycle.

The role requires English fluency and a strong background in validation documentation, with collaboration across Automation, IT, Manufacturing and Projects. 5.5 months contract with expectation of close regulatory alignment.