Vaisesika
Website:
vaisesikaconsulting.com
Job details:
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 environment.
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, Medical Device, Diagnostics, or regulated Life Sciences environments.
- Strong experience with CSV lifecycle, risk-based validation, testing, gap assessment, remediation, and validation documentation.
- Hands-on exposure to Laboratory, Manufacturing, Packaging, or Shopfloor systems.
- Strong knowledge of GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+, Data Integrity, Audit Trails, Electronic Records & Electronic Signatures.
- Strong documentation and review experience across URS, RA, IQ, OQ, PQ, RTM, VSR, SOPs, and Periodic Reviews.
- Strong stakeholder coordination skills across Quality, IT, Business, Vendors, and System Owners.
Preferred System Exposure
Laboratory: LIMS, ELN, CDS, Empower, LabWare, Chromeleon, MODA, Analytical Instrument Software
Manufacturing / Packaging: MES, Serialization, SCADA, PLC/HMI, Batch Record Systems, Packaging Line Systems, ERP Interfaces, Equipment Control Systems, Automation Platforms
Quality Systems: TrackWise, Veeva, MasterControl, ValGenesis, ServiceNow, Document Management Systems
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