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Regulatory Compliance Specialist

2 weeks ago

Chennai, Tamil Nadu, India beBeeCompliance Full time ₹ 18,00,000 - ₹ 25,00,000

Job Title: Regulatory Compliance Specialist

We are seeking a skilled professional to join our team as a Regulatory Compliance Specialist.

This role requires ensuring systems adhere to GxP requirements and is responsible for the full validation lifecycle, from authoring validation deliverables to executing test cases.

The ideal candidate will have a strong understanding of 21 CFR Part 11 and Annex 11, as well as proficiency in SQL for database verification.

Key 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.

Required Skills & Experience:

  • 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.

What We Offer:

  • Opportunity to work with a talented team of professionals in the life sciences industry.
  • Chance to develop your skills and expertise in regulatory compliance and system validation.
  • A dynamic and challenging work environment that fosters growth and learning.