GxP Compliance Specialist

2 days ago


Pune, Maharashtra, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 18,00,000

Job Title: Validation Compliance Expert

About the Role:

We are seeking an experienced Validation Compliance Expert to join our organization. The ideal candidate will have 5-6 years of experience in Computer System Validation (CSV) and regulatory compliance within the life sciences domain.

Main Responsibilities:

  • Provide SME-level support in GxP compliance, Computer System Validation (CSV), and regulatory guidelines like 21 CFR Part 11 and Annex 11.
  • Ensure all validation activities are aligned with a risk-based approach.
  • Author, review, and execute test cases for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)/User Acceptance Testing (UAT).
  • Collaborate with business, QA, and IT teams to ensure full compliance with regulatory and quality standards.

Requirements:

  • 5-6 years of experience in GxP system validation, preferably within the life sciences industry.
  • A solid understanding of CSV methodologies and risk-based validation approaches.
  • Hands-on experience in preparing and executing IQ, OQ, and PQ/UAT test cases.
  • Strong working knowledge of 21 CFR Part 11 and Annex 11.
  • Proficient in SQL for data verification and database testing.

Desired Skills:

  • Familiarity with test management tools like HP ALM or Jira.
  • Excellent documentation, communication, and collaboration skills.


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