Gagan Kumar
Manager | QMS TrackWise Consultant | Crystal Reports | CSV Documentation | Application Operations Lead | Life Sciences | Pharmaceutical | Regulatory Affairs | Project Management | Serving Notice period
- Role
- Manager at PwC India
- Location
- Gurugram, IN
- LinkedIn followers
- 500 followers
About Gagan Kumar
Working as Manager in PwC with total of 8 years of experience. Currently working as TrackWise and Crystal Report Consultant. Good understanding of Audit, Inspection, Customer Complaints, Deviation, Supplier Management, Risk Management and other QMS capabilities Consultant with end to end TrackWise implementation experience which involves TrackWise product installation, product upgrade, business workflow configuration, TrackWise utilities Expert in providing training to the end users for using TrackWise QMS capabilities Rolling out of CSV documentation for Project as per GxP norms. Having good Knowledge of CSV documentation like Change Request, IQ, OQ, PQ, Change Report, URS, FS, SDS, Traceability Matrix, BCP, Release statement, UAT, System test Case, etc. Experienced IT Professional in Pharmaceutical R&D domain, providing and managing the development, validation, and production support of Regulatory, Medical Affairs, Pharmacovigilance, Clinical & Research systems (GxP & non-GxP) Expertise in installation of COTS product like Paraxel Liquent Insight for manager, Paraxel Liquent Insight for Viewing, Atlassian JIRA, etc. Experience in Software license review. Have good experience in License Management and contract compliance Services
Experience
Manager
May 2023 — Present
Education
Birla Institute of Applied Sciences
Electrical, Electronics and Communications Engineering
2011 — 2015
Birla Institute of Applied Sciences
Bachelor's degree
2011 — 2015
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