Job Title: CSV (Computer System Validation) Executive

Experience: 5–7 Years

Industry: Pharmaceutical

Location: Vadodara, Gujarat

Job Purpose:

To plan, execute, and document computer system validation activities ensuring compliance with GxP, 21 CFR Part 11, and data integrity requirements across pharmaceutical manufacturing and quality systems.

Key Responsibilities:

- Prepare and execute CSV documents (URS, FRS, DQ, IQ, OQ, PQ, Traceability Matrix)
- Validate computerized systems (SCADA, PLC, LIMS, DCS, MES, ERP, HVAC BMS, etc.)
- Ensure compliance with 21 CFR Part 11, Annex 11, and Data Integrity guidelines
- Handle change control, deviation, and CAPA related to computer systems
- Coordinate with IT, QA, Engineering, and vendors for system qualification




- Conduct periodic review and revalidation of existing systems
- Maintain validation master plan (VMP) and related documentation
- Support audits (internal, customer, regulatory - USFDA, EU, WHO-GMP)

Requirements:

- B.E./B.Tech/M.Sc. (Engineering, IT, or related field)
- 5–7 years of CSV experience in a pharmaceutical/regulated manufacturing setup
- Robust knowledge of GAMP 5, 21 CFR Part 11, Data Integrity (ALCOA+)
- Hands-on experience with equipment/software qualification
- Good documentation and audit-facing skills

Pay: ₹500,000.00 - ₹700,000.00 per year

Work Location: In person

📌 Executive-CSV (Vadodara)
🏢 Amulya Corporate Services
📍 Vadodara