Senior CSV QA Lead for GMP Systems - 5.5mo

CTC Resourcing Solutions; Stein; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

CTC is seeking a Senior QA Expert CSV (Computerized Systems Validation) for a 5.5 month contract based in the Basel/Stein area, Switzerland. The role focuses on providing CSV QA support for major CAPEX projects, ensuring GMP compliance, regulatory requirements, and internal quality standards throughout the project lifecycle.

Responsibilities include QA review of validation documentation (IQ/OQ/PQ), Change Management and Deviation/Incident Management, and Automation Change Controls (ACCs).

Qualifikationen

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

Aufgaben

• Perform QA review and approval of validation documentation related to MODA (MES) integration, such as FRS, IQ, OQ, PQ and Validation protocols and reports.
• Assess and approve documentation associated with Change Management and Deviation/Incident Management.
• Review and approve Automation Change Controls (ACCs), ensuring system modifications are tested, documented and implemented in GMP-compliant manner.
• Collaborate with Automation, IT, Manufacturing and Project teams to maintain a compliant state of computerized systems.

Kenntnisse

Fluent English

German language

Ausbildung

Bachelor or Master’s degree in Engineering, Life Sciences or related field

Jobbeschreibung

CTC is seeking a Senior QA Expert CSV (Computerized Systems Validation) for a 5.5 month contract based in the Basel/Stein area, Switzerland. The role focuses on providing CSV QA support for major CAPEX projects, ensuring GMP compliance, regulatory requirements, and internal quality standards throughout the project lifecycle.

Responsibilities include QA review of validation documentation (IQ/OQ/PQ), Change Management and Deviation/Incident Management, and Automation Change Controls (ACCs).