Executive-CSV

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
• Strong 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