Sanket Yelge
Computer System Validation - Officer | IT Compliance | CSV | GxP | GDP | GAMP5 | Data Integrity | ALCOA++| 21 CFR PART 11 | ANNEX 11 | QMS | ISO9001| ISO27001|
- Role
- Csv IT - Officer at Ajanta Pharma Ltd
- Location
- Aurangabad, MH, IN
- LinkedIn followers
- 500 followers
Experience
Csv IT - Officer
Oct 2023 — Present · Chhatrapati Sambhajinagar, IN
Computer System ValidationData Integrity ManagementVendor ManagementRisk Management (Management of Vendor Lifecycle, Suppliers/ITVendor/Business Vendor)GxP System AuditPeriodic Review (Conduct Periodic Revisions of GxP Systems, SOPs,and Training Modules)Quality Management System (Drafting and Revising SOP based ongaps in the process or change in process)Draft, Review and Approve Test Cases covering both Positive andNegative Scenarios)Change & Incident Management (Incidence, Deviation, ChangeControl, Discrepancy, Corrective and Preventive Actions (CAPA)GxP Software ValidationElectronic Document Management System (EDMS)Regulatory Compliance (GAMP 5, GxP, 21 CFR Part 11, and Annex 11)Audit Trial Management (PAS|X), Backup Retrieval, User Management,Equipment Qualification and Requalification andManagement.Software Proficiency: PAS|X, Acronis, e-Log,Trims, LIMS.Well-versed with Scripted Testing and Unscripted Testing for Risk-based Approach of Validation.
Education
Government College of Engineering Aurangabad
Master of Computer Applications - MCA, Computer Engineering
Dr. Babasaheb Ambedkar Marathwada University, Aurangabad
Bachelor of Computer Applications , Computer and Information Sciences and Support Services
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