IT Regulatory Specialist

21 hours ago


Vellore, Tamil Nadu, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000

Job Role:

As an IT Compliance Advisor, you will play a critical role in ensuring that our systems and processes meet the highest standards of regulatory compliance.

This includes hands-on experience in compliance and validation roles, including strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5. System validation aligned with regulatory standards requires review of validation artifacts and identification of traceability or documentation gaps.

Key Responsibilities include:

  • Review and preparation of Test Plans, Validation Plans, Risk Assessments, Requirement Traceability Matrix (RTM), Summary Reports.

  • Understanding of the defect lifecycle and validation deliverables, including tools like HP ALM, Jira, TrackWise, Veeva, QMS systems.

Required Skills and Qualifications:

We are looking for candidates with:

  • Hands-on experience in compliance and validation roles.

  • Strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5.

  • Well-versed with System Life Cycle, including hands-on experience with Validation approach, Agile methodology, AIML concepts.

Additional Requirements:

  • Participation in internal/regulatory audits.

  • Strong documentation skills (SOPs, templates, work instructions).

  • Familiarity with risk-based validation and data management.

Benefits:

The ideal candidate should have any graduate degree.



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