IT Governance Specialist

1 week ago


Davangere, Karnataka, India beBeeCompliance Full time ₹ 12,00,000 - ₹ 15,00,000
Job Title: Compliance Specialist

We are seeking an experienced compliance professional to join our team. The ideal candidate will have a strong background in regulatory standards, with hands-on experience in GxP, System Life Cycle, and Methodologies.

Key Responsibilities:
  • Evaluate and ensure compliance with regulatory standards, including GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5.
  • Develop and maintain a thorough understanding of System Life Cycle, Validation approach, Agile methodology, AIML concepts, and Quality Management Systems (QMS).
  • Conduct reviews and prepare validation artifacts, test plans, validation plans, risk assessments, requirement traceability matrix (RTM), summary reports, and defect lifecycle documentation.
  • Maintain knowledge of tools like HP ALM, Jira, TrackWise, Veeva, and QMS systems.
Requirements:
  • 4-7 years of experience in compliance and validation roles.
  • Strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5.
  • Familiarity with system validation aligned with regulatory standards.
  • Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, and QMS systems.
Preferred Skills:
  • Experience with SaaS validation, automation, and vendor audits.
  • Participation in internal/regulatory audits.
  • Strong documentation skills (SOPs, templates, work instructions).
  • Familiarity with risk-based validation and data management.

Educational Qualification: Any Graduate.
Earn attractive compensation and benefits package in this role.



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