Expert Compliance Advisor Position

1 week ago


Thrissur, Kerala, India beBeeCompliance Full time ₹ 10,94,850 - ₹ 20,99,700

Compliance Expert Wanted

We are seeking an experienced Compliance Advisor to join our organization. The successful candidate will have a strong background in compliance, validation, and testing, with a focus on GxP and system life cycle management.

Key Responsibilities:

  • Hands-on experience in compliance and validation roles, with a strong knowledge of regulatory standards such as 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.
  • Well-versed with System Life Cycle, and hands-on experience with Validation approach, Agile methodology, AIML concepts.
  • 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.
  • Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, QMS systems, and knowledge of Quality Management Systems (QMS).
  • Experience in Healthcare, CRO, or Life Sciences environments, and good to have skills in SaaS validation, automation, and vendor audits, participation in internal/regulatory audits, and strong documentation skills (SOPs, templates, work instructions).

Requirements:

  • 4-7 years of experience in compliance and validation roles.
  • Any Graduate degree.

Preferred Qualifications:

  • 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.


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