Data Validation Lead; CSV | GxP Systems
Listed on 2026-10-10
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager -
Pharmaceutical
Regulatory Compliance Specialist
Position:
Data Validation Lead (CSV | GxP Systems)
Location:
Cape Town
Industry: Pharmaceutical Manufacturing
Department:
Validations
/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.
- 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.
- 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.
- Experience with in 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.
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.
Closing date: 16 October 2026
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).