Prakash N.
Lead l Computer System Validation l GxP Compliance l QMS l Data Integrity | Life Science and Pharma | GAMP 5 |
- Role
- Validation Lead Manager at OSI Digital
- Location
- Chandler, AZ, US
- LinkedIn followers
- 500 followers
About Prakash N.
Experienced Validation Professional, with demonstrated history of working in Life Science…
Experience
Validation Lead Manager
Jul 2019 — Present · Irvine, CA, US
Authoring Validation deliverables including Master Validation Plan, URS, FRS, SCS, IQ, OQ and PQ for a GAMP5 Category 5, Custom built logistic Software applications called Cryotrax 2.0 and Cryoport 2.0 and Skytrax Fleet Management GxP Systems with FDA and Compliance Regulations.• Worked on gathering requirements form SME’s for URS and FRS along with extractive researching Cryoportal 1.0• Maintained Project Tracker, Test list trackers and other guiding trackers for development team.• Drafted Installation Qualification (IQ), Operational Qualification (OQ), Performance qualification (PQ) documents for Cryotrax 2.0• Lead the generation of documents for Cryotrax 2.1, 2.2 and 2.3 – Validation Plan, Functional Risk Assessment, System Configuration Specifications, updating Requirements Specification, generating protocols (IQ, OQ/PQ) and then Mapping in RTM.• Contributing on Cryotrax 2.x and Cryoportal 2.x – Requirements gathering, functionality finalize and cleanup, Test protocols generation and execution, patch releases and security upgrades.• Configure and Validate Veeva Vault application for company needs and work then Quality for SOP and WI. Initiate Change Controls, Deviations, Continuous improvement and Complaints.• Configured and Setup JAMA for all Validation deliverables and imported historical documentation. Worked on IQS for Validation document approvals.
Education
Texas A&M University
Master’s Degree
Osmania University
Bachelor of Engineering - BE
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