Senior Regulatory Assurance Specialist

3 days ago


Kottayam, Kerala, India beBeeCompliance Full time ₹ 10,00,000 - ₹ 14,00,000
Job Title:

IT Compliance Advisor

">

">Key Responsibilities:
  • Hands-on experience in compliance and validation roles
  • Strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5
  • System validation aligned with regulatory standards
  • Review of validation artifacts and identification of traceability or documentation gaps


Required Skills and Qualifications:
  1. Well-versed with System Life Cycle
  2. Hands-on experience with Validation approach, Agile methodology, AIML concepts
  3. Review and preparation of: Test Plans, Validation Plans, Risk Assessments
  4. Requirement Traceability Matrix (RTM), Summary Reports
  5. Understanding of the defect lifecycle and validation deliverables
  6. Knowledge of Quality Management Systems (QMS)
  7. Experience in Healthcare, CRO, or Life Sciences environments


">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:

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