SAP Computer System Validation (CSV) Specialist

Ref: BBBH67763_1785936645

SAP Computer System Validation (CSV) Specialist

SAP Computer System Validation (CSV) Specialist is required ASAP for a contract engagement with one our leading clients.

Role Overview
We are looking for an experienced SAP Computer System Validation (CSV) Specialist to support the remediation of a pharmaceutical computerised system. The successful candidate will have hands-on experience delivering CSV activities within a GxP regulated environment and be confident working independently to produce audit-ready validation documentation.

Key Responsibilities

• Perform validation gap assessments and risk assessments.
• Create and remediate validation plans, reports and requirements traceability documentation.
• Prepare and maintain GxP validation documentation.
• Support Operational Qualification (OQ) and Performance Qualification (PQ) testing.
• Produce audit-ready validation evidence and documentation.
• Ensure compliance with GxP, GAMP 5, FDA 21 CFR Part 11 and EU Annex 11 requirements.
• Work closely with project teams to ensure validation activities are completed to the required standard.

Required Skills & Experience

• Minimum 3 years’ hands-on Computer System Validation (CSV) experience.
• Previous experience within the pharmaceutical or life sciences industry is essential.
• Strong understanding of GxP, GAMP 5, FDA 21 CFR Part 11 and EU Annex 11.
• SAP validation experience is strongly preferred.
• Able to work independently and deliver high-quality documentation under tight project deadlines.

Other details:

• Location: Remote + Poland
• Start: ASAP
• Duration: 12 Months +

Whitehall Resources are leading ERP Recruitment specialist in the provision of SAP, Oracle & IT recruitment in the UK and Internationally

All of our opportunities require that applicants are eligible to work in the specified country/location, unless otherwise stated in the job description.

Whitehall Resources are an equal opportunities employer who value a diverse and inclusive working environment. All qualified applicants will receive consideration for employment without regard to race, religion, gender identity or expression, sexual orientation, national origin, pregnancy, disability, age, veteran status, or other characteristics.

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