Validation Specialist

4 weeks ago

Gurugram, India Obrimo Technologies Full time

We are looking for an experienced
GxP Validation Specialist
to join our Quality & Compliance team in Gurgaon. The ideal candidate will have strong expertise in
GxP system validation, computer system validation (CSV), and regulatory compliance
, ensuring adherence to industry standards (FDA, EMA, GAMP 5). This role requires hands-on validation experience, attention to detail, and excellent communication skills.

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.

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