
IT Compliance Expertise Advisor
2 weeks ago
Job Title: Compliance Expertise Advisor
A trusted IT compliance advisor with 4-7 years of experience is sought after to ensure seamless system validation and adherence to regulatory standards in the healthcare industry.
About This Role- We are seeking a skilled professional to validate and maintain compliance with GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5 regulations.
- Validate and maintain system validation aligned with regulatory standards
- Review of validation artifacts and identification of traceability or documentation gaps
- Implement System Life Cycle methodologies
- Hands-on experience with Validation approach, Agile methodology, AIML concepts
- Prepare Test Plans, Validation Plans, Risk Assessments, Requirement Traceability Matrix (RTM), Summary Reports
- Understanding of the defect lifecycle and validation deliverables
- Utilize tools like HP ALM, Jira, TrackWise, Veeva, 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
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