
Senior Regulatory Assurance Specialist
3 days ago
IT Compliance Advisor
">">Key Responsibilities:
- Hands-on experience in compliance and validation roles
- Strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5
- System validation aligned with regulatory standards
- Review of validation artifacts and identification of traceability or documentation gaps
Required Skills and Qualifications:
- Well-versed with System Life Cycle
- 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
- Understanding of the defect lifecycle and validation deliverables
- Knowledge of Quality Management Systems (QMS)
- Experience in Healthcare, CRO, or Life Sciences environments
">Preferred Skills:
- 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:
-
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