Senior QA Expert CSV / Senior QA Expertess CSV

Join Our Team as a Senior QA Expert CSV

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, supporting 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 in both the chemical and biotechnology sectors, is seeking a:

Senior QA Expert CSV (Computerized Systems Validation)

This is 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, including 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's or Master's degree in Engineering, Life Sciences, or a related field.
• Significant experience in the GMP regulated pharmaceutical industry.
• Fluency in English; German language skills would be an advantage.

If you are interested in learning more about CTC and this exciting opportunity, please apply online using the form below. Please note that only applications matching the job profile will be considered.