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
Positive 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