GxP Validation Lead with good SQL knowledge (Immediate Joiner only)

Job Title:

Experience:

Location:

Employment Type:

Role Overview:

We are seeking a GxP Validation Specialist with hands-on experience in Computer System Validation (CSV), regulatory compliance & strong knowledge in SQL. 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

  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:

• 5-6 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.
• Strong SQL knowledge for data verification and database testing.
• Good documentation, communication, and collaboration skills.

Preferred Qualifications:

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