
IT Governance Specialist
1 week ago
We are seeking an experienced compliance professional to join our team. The ideal candidate will have a strong background in regulatory standards, with hands-on experience in GxP, System Life Cycle, and Methodologies.
Key Responsibilities:- Evaluate and ensure compliance with regulatory standards, including GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5.
- Develop and maintain a thorough understanding of System Life Cycle, Validation approach, Agile methodology, AIML concepts, and Quality Management Systems (QMS).
- Conduct reviews and prepare validation artifacts, test plans, validation plans, risk assessments, requirement traceability matrix (RTM), summary reports, and defect lifecycle documentation.
- Maintain knowledge of tools like HP ALM, Jira, TrackWise, Veeva, and QMS systems.
- 4-7 years of experience in compliance and validation roles.
- Strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5.
- Familiarity with system validation aligned with regulatory standards.
- Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, and QMS systems.
- 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: Any Graduate.
Earn attractive compensation and benefits package in this role.
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