
Compliance Specialist
21 hours ago
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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