Brajesh Parmar
Sr. Tech Lead Consultant at HCLTech
- Role
- Senior Technical Lead at HCLTech
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Brajesh Parmar
Experience of DGFT, US and EU Serialization project to make parent and child…
Experience
Senior Technical Lead
Jun 2024 — Present · Hyderabad, IN
Core Competencies:Computerized System Validation (CSV) using V-Model and Agile methodologyComputer Software Assurance (CSA) implementationAI Validation aligned with evolving regulatory frameworksGxP Compliance, 21 CFR Part 11, Annex 11, and GAMP 5 adherenceSoftware Development Life Cycle (SDLC) documentation and reviewPreparation & review of:Risk AssessmentValidation Master Plan (VMP)User Requirements Specification (URS)Functional Requirement Specification (FRS)Software Design Specification (SDS)Hardware Design Specification (HDS)Installation/Operational/Performance Qualification (IQ/OQ/PQ)Traceability MatrixValidation Summary ReportsSupplier Qualification & Audits (remote and on-site) as per GAMP 5ERES Assessment, Data Integrity (ALCOA+), and Penetration TestingCode Review, Module/Unit Testing, and Integration TestingCAPA Management for software defects, change controls, and audit findingsLeading and supporting regulatory and customer inspections for computerized systems
Education
Rajiv Gandhi Prodyogiki Vishwavidyalaya
Bachelor of Pharmacy (B.Pharm.)
G.R.Y. Institute of Pharmacy, Khargone M
2007 Bachelor of Pharmacy
2003 — 2007
Bhupal Noble's College of Pharmacy, Udaipur, Rajasthan University of Health & sciences
M. Pharma
2007 — 2010
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