Job description
We are looking for a Computer System Validation (CSV) Executive with 3+ years of experience in validation activities for software applications used in pharmaceutical/IT or regulated environments. The candidate will support validation documentation, testing, compliance verification, and implementation activities for pharma compliance software applications. Roles & Responsibilities: Prepare and review CSV documents such as:
Roles & Responsibilities
- Prepare and review CSV documents such as:
- URS (User Requirement Specification)
- FRS/SRS (Functional/System Requirement Specification)
- Risk Assessment
- IQ, OQ, PQ Protocols
- Traceability Matrix
- Validation Summary Reports
- Execute validation test cases and document results.
- Verify compliance with:
- 21 CFR Part 11
- EU Annex 11
- GAMP 5
- GxP guidelines
- Coordinate with development, QA, and implementation teams for issue resolution.
- Perform software review and compliance checks.
- Support audit preparation and documentation activities.
- Assist in change control, deviation handling, and CAPA-related validation activities.
- Maintain validation records and ensure proper documentation practices.
Required Skills
- Basic understanding of Computer System Validation (CSV)
- Knowledge of pharma regulatory requirements
- Familiarity with validation lifecycle and documentation
- Good understanding of SDLC and software testing concepts
- Knowledge of MS Office documentation tools
- Good communication and documentation skills
- Ability to interact with clients and internal teams professionally
Preferred Skills
- Exposure to Pharma QMS, EDC, IWRS, CTMS, LIMS, LMS, or ERP applications
- Understanding of audit trails, electronic signatures, and access controls
- Knowledge of SQL or basic database concepts is an advantage
- Experience in handling validation documentation in regulated environments
Educational Qualification
- B.Pharmacy / M.Pharmacy
- B.Tech / M.Tech
- B.Sc / M.Sc (Life Sciences, Biotechnology, Microbiology, Chemistry)
- Any equivalent qualification
Role: Quality Assurance and Testing -
Pay: ₹289,434.15 - ₹962,737.55 per year
Work Location: In person
