Validation Specialist

GxP Validation Specialist

Key Responsibilities

• Perform

  end-to-end validation activities

  for GxP-regulated systems, including Computer System Validation (CSV).
• Prepare and review validation deliverables such as

  URS, FS, DS, IQ, OQ, PQ, traceability matrix, and validation summary reports

  .
• Ensure compliance with

  21 CFR Part 11, Annex 11, GAMP 5, FDA, and other global regulatory requirements

  .
• Collaborate with IT, QA, and business teams to plan, execute, and document validation activities.
• Support periodic reviews, audit readiness, and remediation activities for validated systems.
• Maintain validation documentation in accordance with

  SOPs and quality standards

  .
• Provide support during

  internal/external audits and inspections

  .

Required Skills & Qualifications

• 5+ years

  of experience in

  GxP system validation / CSV

  .
• Strong knowledge of

  regulatory guidelines (21 CFR Part 11, Annex 11, GAMP 5, FDA, EMA, ICH, MHRA)

  .
• Hands-on experience in preparing and reviewing

  validation protocols and reports

  .
• Familiarity with

  ERP, LIMS, MES, Laboratory Instruments, or other GxP systems

  .
• Excellent written and verbal communication skills.
• Strong analytical, documentation, and problem-solving abilities.

Good to Have

• Experience in

  pharmaceuticals, life sciences, or medical devices

  domain.
• Knowledge of

  risk-based validation approach

  .
• Exposure to

  cloud-based GxP systems

  .
• Familiarity with

  21 CFR Part 820 (QSR)

  or ISO 13485.