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Data Validation Lead (CSV | GxP Systems) Cape Town
Job Location:
Job Location:
Cape Town - South Africa
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
10 October 2026 (3 days ago)
Posted:
Application Deadline:
7 January 2027
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Introduction
Position: Data Validation Lead (CSV GxP Systems)
Location: Cape Town
Industry: Pharmaceutical Manufacturing
Department: Validations
REF: MVG/DVL
A leading pharmaceutical manufacturer is seeking a Data Validation Lead to provide site-wide support for Computer Systems Validation (CSV) and Data Integrity (DI) activities ensuring critical systems remain compliant validated secure and inspection-ready. Reporting to the Validation Manager this role will drive compliance across laboratory manufacturing quality and business systems while fostering a culture of data integrity and operational excellence.
Key Responsibilities
- Lead site-wide CSV and Data Validation initiatives across regulated GxP systems.
- Develop implement and maintain Data Validation and CSV strategies policies and procedures.
- Ensure compliance with FDA 21 CFR Part 11 Annex 11 GMP and GAMP requirements.
- Oversee qualification and validation activities including DQ IQ and OQ.
- Support audits inspections investigations CAPAs deviations and change controls.
- Partner with Quality Manufacturing QC Regulatory Affairs and IT teams to ensure ongoing compliance and validation readiness.
Essential Requirements
- Degree or Diploma in Computer Science Information Systems Engineering Automation
- Solid grounding in Chemistry Biology Biotechnology Pharmacy or a related scientific discipline.
- Min 3-5 years experience in pharmaceutical validation including CSV Data Integrity or Quality Systems within a regulated pharmaceutical or biotechnology environment.
- Strong knowledge of FDA 21 CFR Part 11 Annex 11 GAMP GMP and Data Validation principles.
- Experience validating computerized systems such as LIMS EDMS laboratory systems and other GxP-regulated platforms.
- Strong analytical problem-solving investigation and stakeholder engagement skills.
Advantageous
- Experience within sterile aseptic vaccine or biotechnology manufacturing environments.
- Successful exposure to local and international regulatory inspections and audits.
- Certifications in Quality Assurance Regulatory Affairs Data Integrity or Validation.
- Project management and business planning experience.
Ideal Candidate
We are looking for a technically strong CSV and GxP Systems professional who combines pharmaceutical validation expertise with a scientific foundation in Chemistry Biology Biotechnology or a related discipline. The successful candidate will be comfortable influencing stakeholders across the site driving compliance initiatives and ensuring the integrity of data and computerized systems throughout the product lifecycle.
Apply to response at REF: MVG/DVL
Closing date: 16 October 2026
