Regulatory Assurance Expert

2 days ago


Kollam, Kerala, India beBeeCompliance Full time ₹ 18,00,000 - ₹ 24,00,000

Job Title: Compliance Assurance Specialist

About This Role

We are seeking a highly skilled Compliance Assurance Specialist to join our team.

Key Responsibilities:
  • Compliance and Validation
  • Hands-on experience in compliance and validation roles, with strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5.
  • System validation aligned with regulatory standards, including review of validation artifacts and identification of traceability or documentation gaps.
Required Skills and Qualifications:
  • System Life Cycle and Methodologies
  • Well-versed with System Life Cycle, with hands-on experience with Validation approach, Agile methodology, AIML concepts.
  • Testing/Validation Experience
  • Review and preparation of Test Plans, Validation Plans, Risk Assessments, Requirement Traceability Matrix (RTM), Summary Reports, and understanding of the defect lifecycle and validation deliverables.
  • Tools and Technologies
  • Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, QMS systems.
Benefits
  • Quality & Domain Expertise
  • Knowledge of Quality Management Systems (QMS) and experience in Healthcare, CRO, or Life Sciences environments.
Good to Have Skills
  • Experience with SaaS validation, automation, and vendor audits, participation in internal/regulatory audits, strong documentation skills (SOPs, templates, work instructions), and familiarity with risk-based validation and data management.
Educational Qualification

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