IT Compliance Advisor

Project Role:

Experience:

Job Location:

Work Mode:

Must Have Skills:

Domain Knowledge:

Compliance and Validation

• 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

System Life Cycle and Methodologies

• Well-versed with System Life Cycle
• Hands-on experience with Validation approach, Agile methodology, AIML concepts

Testing/Validation Experience

• Review and preparation of: Test Plans, Validation Plans, Risk Assessments
• Requirement Traceability Matrix (RTM), Summary Reports
• Understanding of the defect lifecycle and validation deliverables

Tools and Technologies

• Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, QMS systems

Quality & Domain Expertise

• Knowledge of Quality Management Systems (QMS)
• Experience in Healthcare, CRO, or Life Sciences environments

Good to Have 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: