CSV (Computer System Validation)

Computer System Validation (CSV) Specialist

Key Responsibilities:

• Develop and execute

  CSV lifecycle documentation

  : URS, Risk Assessment, IQ, OQ, PQ, Traceability Matrix, and Validation Summary Reports.
• Ensure compliance with

  21 CFR Part 11

  ,

  Annex 11

  ,

  GAMP 5

  , and

  GxP

  guidelines.
• Manage validation of GxP-critical systems including

  LIMS, QMS, ERP, PLC/SCADA

  , and

  electronic batch record (EBR)

  platforms.
• Collaborate with cross-functional teams (QA, IT, Manufacturing, Lab) for smooth implementation and validation of computerized systems.
• Review and approve vendor-supplied documentation and software qualification deliverables.
• Participate in audits and inspections; ensure readiness of CSV documentation and responses to regulatory bodies.
• Maintain

  Change Control and Periodic Review

  activities for validated systems.
• Provide training to stakeholders on system validation procedures and compliance expectations.

Required Qualifications:

• B.Pharm

  from a recognized university (M.Pharm or additional certifications in CSV is a plus).

• 5–8 years

  of relevant experience in

  Computer System Validation

  in a regulated pharmaceutical or life sciences environment.
• Strong working knowledge of

  LIMS

  ,

  TrackWise

  ,

  SAP

  ,

  MES

  , or other pharma-grade software systems.
• Familiarity with

  data integrity principles

  , GAMP 5 guidelines, and risk-based validation approaches (CSA exposure is a plus).
• Good documentation practices and ability to work across cross-functional teams.

Key Skills & Competencies:

• Expertise in CSV lifecycle and compliance frameworks
• Strong understanding of pharma shop floor and laboratory processes
• Risk assessment & validation planning
• Cross-functional communication and stakeholder management
• Audit preparedness and regulatory interaction experience