Senior QA Expert CSV (Computerized Systems Validation - 7070)

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 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.