GxP Validation Specialist

13 hours ago

Chennai, Tamil Nadu, India Archimedis Digital Full time US$ 90,000 - US$ 1,20,000 per year

Job Title:
GxP Validation Specialist

Experience:
3–5 Years

Location:
Chennai/Pune

Employment Type:
Full-time

Role Overview:

We are seeking a GxP Validation Specialist with hands-on experience in Computer System Validation (CSV) and regulatory compliance. The ideal candidate will support system qualification activities, ensure adherence to GxP requirements, and work closely with cross-functional teams to deliver high-quality validation deliverables.

Key Responsibilities:

  • Provide SME-level support in
    GxP compliance
    ,
    CSV
    ,
    21 CFR Part 11
    , and
    Annex 11
    guidelines.
  • Understand business and system requirements to author and execute test cases for -
    Installation Qualification (IQ)
    ,
    Operational Qualification (OQ)
    , and
    Performance Qualification (PQ)/User Acceptance Testing (UAT)
    .
  • Author and review validation deliverables including plans, reports, and traceability matrices.
  • Perform defect logging, tracking, and resolution using
    HP ALM
    or
    Jira
    .
  • Conduct basic
    SQL queries
    for database verification and support
    DB testing
    activities.
  • Collaborate with business, QA, and IT teams to ensure compliance with regulatory and quality standards.

Required Skills & Experience:

  • 3–5 years of experience in
    GxP system validation
    within life sciences domain.
  • Solid understanding of
    CSV methodologies
    and
    risk-based validation approaches
    .
  • Working knowledge of
    21 CFR Part 11
    and
    Annex 11
    requirements.
  • Hands-on experience in preparing and executing
    IQ, OQ, PQ/UAT
    test cases.
  • Familiarity with
    HP ALM
    or
    Jira
    for test management and defect tracking.
  • Basic SQL knowledge for data verification and database testing.
  • Strong documentation, communication, and collaboration skills.

Preferred Qualifications:

  • Experience with regulatory audits and inspections.
  • Exposure to Agile or Waterfall SDLC methodologies in a GxP environment.

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