Computer System Validation (CSV) Professional

Location: Nashik
Work Mode: Work from Office – 5 Days
Experience: 6–16 Years
Industry: Pharmaceutical / Biotechnology / Medical Devices / Diagnostics / Life Sciences
Role: Computer System Validation (CSV)
About the Role
We are looking for an experienced Computer System Validation (CSV) professional with strong exposure to Laboratory, Manufacturing, Packaging, and Quality systems in a regulated Life Sciences / GxP setting.
The role involves CSV gap assessments, remediation, validation lifecycle execution, documentation, testing, and audit readiness for computerized systems.
Key Responsibilities
Perform CSV gap assessments for laboratory, manufacturing, packaging, and shopfloor systems against GxP, regulatory, and internal quality requirements.
Execute remediation plans for validation, documentation, compliance, and data integrity gaps.
Lead/support the end-to-end CSV lifecycle, including validation planning, risk assessments, requirements review, test strategy, protocol development, execution, traceability, deviations,



and validation summary.
Prepare/review URS, FRS, Risk Assessments, IQ/OQ/PQ, RTM, test scripts, deviation reports, VSRs, SOPs, and periodic review documents.
Support validation of LIMS, ELN, CDS, MES, serialization, SCADA, PLC/HMI, batch records, packaging systems, equipment interfaces, automation, and data acquisition systems.
Collaborate with Quality, IT, Manufacturing, Packaging, Laboratory, Engineering, Automation, Business SMEs, vendors, and system owners.
Ensure compliance with GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+, audit trails, electronic records/signatures, and data integrity requirements.
Review system changes, deviations, incidents, CAPAs, and periodic reviews from a CSV/compliance perspective.
Ensure CSV documentation is complete, accurate, traceable, and audit/inspection ready.

Required Skills & Experience
6–16 years of hands-on CSV experience in Pharmaceutical, Biotechnology,

📌 Computer System Validation (Nashik)
🏢 Vaisesika
📍 Nashik