- End-to-end Validation and testing activities and compliance execution of the IT compliance services in scope for the applicable in-scope systems
- Conducting the IT Risk Assessment of the IT System (Periodic assessment or upon major changes / Adhoc Request)
- Author / Review of User Review Report (access review report) annually
- Author Supplier Assessment report
- Define/refine the O&M; (Operations & Maintenance) procedure report for the applications in scope
- IT System List report review annually
- Author IT PSE (Periodic System Evaluation) Report as per the schedule -
- Author Decommission Plan / Report
- Support Validation of small projects/releases - This includes authoring of IT Risk Assessment, Implementation Plan/Report, Supplier Assessment Report, IV, OV, PV Change request, Personal data assessment, Requirements, Design Documents, Configuration documents, etc.
- Deviation / CAPA Provide assistance / guidance to team (as required) towards Deviation / CAPA management
- Support Audit & Inspection support - Provide offline clarification and coordinate on the audit/inspection evidence requests, on need basis
- All IT GxP compliance activities
- Provide GxP compliance consultation and advisory support
- Recommend industry best practices on the IT GxP Compliance services in scope
- Highlight risks / issues proactively and ensure stakeholders are well informed
- Support in maintaining compliance for the IT systems in scope
Experience- 3-5 Years Location-Bengaluru
Notice Period- 30 Days Max (Officially)
Note: Please do not apply if your experience or notice period do not match, else your profile would not be shortlisted.