Location: Mira Road, Mumbai
Role Overview:
To ensure all computerized systems used in GxP (Good Practice) environments comply with regulatory requirements through structured Computer System Validation (CSV) practices, in alignment with FDA 21 CFR Part 11, GAMP 5, and other applicable guidelines
Key Responsibilities:
Execute and manage CSV lifecycle activities including planning, risk assessment, URS (User Requirement Specification), FS (Functional Specification), testing (IQ/OQ/PQ), and final reporting.
Draft and review validation documentation (Validation Plan, Traceability Matrix, Protocols, Summary Reports).
Perform periodic review and revalidation of existing systems in accordance with change control and risk assessments.
Collaborate with cross-functional teams including IT, QA, QC, Production, and Vendors to ensure validation compliance.
Support audits and inspections by presenting validation documentation and addressing queries.
Ensure systems are compliant with data integrity principles and applicable global regulatory standards (FDA, MHRA, EMA, etc.).
Stay updated on current regulatory expectations, GAMP 5, and industry best practices.
Key Competencies:
Sound knowledge of validation principles (GAMP 5, 21 CFR Part 11, Annex 11).
Familiarity with QMS systems, SDLC methodologies (Agile/Waterfall), and documentation standards.
Strong analytical and technical writing skills.
Ability to interpret regulatory guidelines and apply them practically.
Attention to detail, compliance-focused, and good organizational skills.
Experience:
- 2–3 years of hands-on experience in computer system validation within pharmaceutical, biotech, or medical device industry.
- Experience with ERP, LIMS, QMS, or MES validation is a plus.
- Familiarity with audit trails, data integrity compliance, and vendor qualification is an advantage.
Qualification:
- B.E./B.Tech in Computer Science, IT.
- Biotechnology Electronics OR M.Sc./B.Sc. in Life Sciences Pharmacy, or related discipline