Job
Description
About The Role : Ensure Review and Approval of planning, execution and documentation of Change Management Activities (at Asses / Review states); along with associated lifecycle documents and test documents for Change Lifecycle by maintaining the IT Compliance standards. Responsible for the review and approval of Test Scripts and executed test cases to assure compliance with good documentation practices. Individual contributor for Quality, Compliance, and Good Documentation Practices Experienced in authoring & review of validation documentation such as URS, FRS, and SDS, Validation Plan, Issues Log, Design Review, IQ Protocol/Report, OQ Protocol/Report, Test Cases, Test executions, Trace Matrix, and Validation report, etc. Working on Defect Management, CAPA and Deviation documentation, review and approval. working on testing and validation management tools like ServiceNow, HP ALM, Document Management (GDRS/ EDMS), or equivalent tools, etc. Research in supporting systems (e.g., GDRS, ServiceNow, EDMS, etc.) that store the records to be reviewed Sign & Approve request forms for HPQC as IT Compliance approver. Primary Skills Ensure Review and Approval of planning, execution and documentation of Change Management Activities (at Asses / Review states); along with associated lifecycle documents and test documents for Change Lifecycle by maintaining the IT Compliance standards. Working on Defect Management, CAPA and Deviation documentation, review and approval. working on testing and validation management tools like ServiceNow, HP ALM, Document Management (GDRS/ EDMS), or equivalent tools, etc. Secondary Skills Responsible for the review and approval of Test Scripts and executed test cases to assure compliance with good documentation practices. Experienced in authoring & review of validation documentation such as URS, FRS, and SDS, Validation Plan, Issues Log, Design Review, IQ Protocol/Report, OQ Protocol/Report, Test Cases, Test executions, Trace Matrix, and Validation report, etc. Research in supporting systems (e.g., GDRS, ServiceNow, EDMS, etc.) that store the records to be reviewed Sign & Approve request forms for HPQC as IT Compliance approver. Individual contributor for Quality, Compliance, and Good Documentation Practices
