Senior QA Expert CSV (Computerized Systems Validation) (7070)

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 is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed.

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a:

Senior QA Expert CSV (Computerized Systems Validation)

for a 5.5 month-contract role based in the Basel/Stein area, Switzerland.

In this role, you will provide CSV QA support for major CAPEX projects, ensuring compliance with GMP, regulatory requirements, and internal quality standards throughout the project lifecycle.

Main responsibilities:

• Perform QA review and approval of validation documentation related to MODA (MES) integration, such as Functional Requirement Specifications (FRS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (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 that automation system modifications are appropriately assessed, tested, documented, and implemented in compliance with GMP and data integrity requirements.
• Collaborate with Automation, IT, Manufacturing, and Project teams to ensure computerized systems are implemented and maintained in a compliant state.

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required.
• 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.