Site-wide CSV & Data Validation Lead (GxP Systems)

MVG Recruitment

Cape Town

Presencial

ZAR 900.000 - 1.200.000

Jornada completa

Hace 2 días
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Descripción de la vacante

MVG Recruitment is seeking a Data Validation Lead to oversee site-wide CSV and Data Integrity activities for a pharmaceutical manufacturing site in Cape Town. You will drive validation readiness and ensure systems remain compliant, validated, and secure.

Reporting to the Validation Manager, you will collaborate with Quality, Manufacturing, QC, Regulatory Affairs and IT to maintain data integrity and support inspections and CAPAs throughout the product lifecycle.

Formación

  • 3–5 years in pharmaceutical validation (CSV, Data Integrity or Quality Systems) in a regulated setting.
  • Experience validating computerized systems such as LIMS, EDMS or other GxP platforms.
  • Strong knowledge of FDA 21 CFR Part 11, Annex 11, GMP, and Data Validation principles.

Responsabilidades

  • Lead site-wide CSV and Data Validation initiatives across regulated GxP systems.
  • Develop, implement, and maintain CSV strategies, policies, and procedures.
  • Support audits, inspections, CAPAs, deviations, and change controls.
  • Partner with Quality, Manufacturing, QC, Regulatory Affairs, and IT to ensure ongoing compliance.

Conocimientos

CSV validation
GxP systems
Data integrity
Regulatory compliance
Stakeholder engagement

Educación

Degree/Diploma in CS/IS/Engineering
Science background (Chemistry/Biology/Biotechnology/Pharmacy)

Herramientas

LIMS
EDMS
GxP lab systems

Descripción del empleo

MVG Recruitment is seeking a Data Validation Lead to oversee site-wide CSV and Data Integrity activities for a pharmaceutical manufacturing site in Cape Town. You will drive validation readiness and ensure systems remain compliant, validated, and secure.

Reporting to the Validation Manager, you will collaborate with Quality, Manufacturing, QC, Regulatory Affairs and IT to maintain data integrity and support inspections and CAPAs throughout the product lifecycle.

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