Job Description

Job Description

:

Experience Required: 5–8 years Domain Expertise: Pharmaceutical industry, Pharmacovigilance, GxP compliance, Quality Assurance, Audit processes, 21 CFR Part 11, GDPR, and GAMP 5

Experienced in regulatory compliance and auditing, with a strong ability to design, implement, and enforce policies that meet all legal and organizational requirements. Adept at evaluating high‑risk areas to ensure rigorous internal and external compliance. Good Clinical Practice (GCP)

Key Responsibilities

  • Lead Computer System Validation (CSV) activities in alignment with GxP , 21 CFR Part 11 , GDPR , and GAMP 5 guidelines.
  • Develop, review, and approve validation documentation including protocols, reports, and risk assessments.
  • Ensure systems comply with regulatory expectations for electronic records, electronic signatures, and data privacy.
  • Apply GAMP 5 principles...

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