Brajesh Parmar

Background

About Brajesh Parmar

Experience of DGFT, US and EU Serialization project to make parent and child relationship between bottle to shipper and shipper to pallet- Experience of Track and trace system-Preparation and review of software development life cycle documents such as Risk Assessment, Validation master plan, User Requirements specification, Qualification plans, Validation summary report, Traceability Matrix, IQ/OQ/PQ Test scripts etc- Preforming GxP Assessment, ERES assessment, 21 CFR part 11, GAMP 5 and other compliance requirements and adherence- Supplier assessment as per GAMP-5 though the postal or on site auditing them for their competency for development of software- Review of Functional requirement specification (FRS), software design specification (SDS), Hardware design specification (HDS) and design specification (DS)- Review of software development document such as code review documents, Module (unit) Testing documents, Integration Testing, Penetration Testing, ERES assessment testing etc- Identify and Categorize software defect and track them through initiating the CAPA for their closure- Establishing and implementing corrective and preventive actions and process improvements initiatives for CSV projects- Facing the regulatory, customer, and Quality System related inspections for all computerized systems- Experienced Quality Assurance with a demonstrated history of working in the pharmaceuticals industry. Skilled in Equipment Qualification, Process validation, Cleaning Validation and Computer system Validation with a M. Pharma focused in Pharmacology from Bhupal Noble's College of Pharmacy, Udaipur, Rajasthan University of Health & sciences.