Professional II – CSV & Regulatory Compliance Consultant at Capgemini technologies private Ltd (2023-01 – Present)
Clients: CSL Behring & Cepheid. Projects: SAP S/4HANA Validation project, Serialization IT infrastructure & Periodic revalidation of Trackwise (QMS)
- Authored and reviewed all end-to-end validation of SAP S/4HANA in GxP environment
- Authored and reviewed of validation deliverables (URS, FS, DS, IQ, OQ, PQ, RTM, VSR)
- Performed periodic revalidation as per the system timeline frequency
- Authored and Reviewed Infrastructure qualification deliverables (Impact Assessment, TDS, Qualification plan, IQ, System inventory, QSR)
- Collaborating with cross functional teams for better improvement of business requirements
- Provide training to system users on compliance, data integrity, and system usage.
Associate: CSV & QA Compliance at Cognizant technology Solution (2022-01 – 2023-12)
Client: Abbott & Bio-Marin. Project: Salesforce CRM Implementation & Validation (GxP System)
- Authored and reviewed all validation deliverables (VP, URS, FRS, FRA, CS/DS, IQ, OQ, PQ, RTM, VSR) as per GxP
- Responsible for defining and documenting validation strategy for GxP IT systems.
- Performed periodic revalidation
- Collaborating with cross functional teams for better improvement of business requirements
Senior Quality Analyst: QA Compliance at M/S Aurobindo Pharmaceuticals Ltd, Unit 15 (2020-01 – 2022-12)
Projects: Standalone Manufacturing, Packing Equipment's & Analytical instruments software Qualification, MES, NICHELON, QMS
- Responsible for end-to-end validation of projects as per GAMP 5, 21CFR PART 11
- Authored and reviewed all validation deliverables (VP, URS, FRS, FRA, DS, IQ, OQ, PQ, RTM, VSR) as per GxP.
- Authored and reviewed GXP assessment, ER/ES applicability assessment, GAMP categorization and classification, Supplier assessment
- Installation, Commissioning and Validation of all the Equipment's and Applications
- Change control management: Evaluation and approval of changes with impact assessment from quality and regulatory perspective
- Provide training to system users on compliance, data integrity and system usage for continue learning process.
- Ensuring periodic system revalidation and compliance with lifecycle management practices.
Quality Professional at Eisai Pharmaceuticals India Pvt.Ltd (2018-01 – 2020-12)
Projects: Trackwise, BMS, DSRS
- Authored and reviewed all equipment qualification and Software validation of GxP systems
- Authored and reviewed all validation End to End deliverables
- Performing Periodic revalidation
- Coordinating with cross functional teams for timely completion of all activities as per the schedule
