Compliance Specialist

21 hours ago


Ghaziabad, Uttar Pradesh, India beBeeValidation Full time ₹ 10,00,000 - ₹ 20,00,000

Job Title: Compliance Specialist

We are seeking a seasoned Compliance Specialist to oversee compliance and validation initiatives across our organization.

Key Responsibilities:

  • Expertise in GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5 regulatory standards.
  • Hands-on experience with system validation, review of validation artifacts, and identification of gaps.
  • Proven track record of reviewing and preparing Test Plans, Validation Plans, Risk Assessments, Requirement Traceability Matrix (RTM), and Summary Reports.
  • Familiarity with defect lifecycle and validation deliverables, as well as tools like HP ALM, Jira, TrackWise, Veeva, and QMS systems.

Requirements:

  • 4-7 years of experience in a related field, preferably in Healthcare, CRO, or Life Sciences environments.
  • Strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5.
  • Good communication and documentation skills, with the ability to work effectively in a team environment.

Education:

  • Any Graduate degree is acceptable.

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