Vipull Giri G.

A seasoned professional with over 19 years of experience in the pharmaceutical and life sciences industries, specializing in the Process Engineering, Project Management, CQV (Commissioning, Qualification and Validation), Quality Management System and GMP implementation, Operational Excellence and Process Improvement Specialist for Sterile Formulations of Large Volume Parenteral (BFS/ISBM), Small Volume Parenteral (Glass Vials, PFS, FFS, Ampoules, Dry powders, Lyophilizers), Fill-Finish (Biologics, Vaccines), Cosmetics, Ointments, Syrup, Oral Solid Dosages (Tablets, Capsules), Sterile API and Chemicals, and Cosmetics Manufacturing. My expertise spans sterile injectables, biologics, vaccines, oncology drugs, and advanced skincare formulations, including technologies like lyophilization, fermentation, upstream and downstream processes, cell culture, purification and formulation, bioactive encapsulation, microemulsification, and nanoencapsulations. Recognized as an expert in delivering a spectrum of services for pharma, cosmetics, chemicals (API), food, and beyond. Expert in Health Canada, FDA, PIC/S, ICH, WHO-GMP, ISO guidelines implementation. Proficient in designing manufacturing facilities, commissioning qualification validation, project management, quality management system development, audit and compliance, risk management, Pharma 4.0 etc. - Expert in Plant layout designing for any kind of Pharmaceutical dosage forms facility such as Sterile Formulations, OSD, Ointment, Syrup, API, Injectables, PFS, BFS, FFS etc. - Expert in Plant layout designing for Cosmetics, Food and beverages, Chemicals or any other kind of manufacturing facilities. - Expert in implementing Quality Management System in manufacturing facility as per regulatory guidance with Good Manufacturing Practices. - Expert in preparing documentation with SOPs - Standard Operating Procedures - Drafting for any kind of manufacturing processes and other procedures. - Expert in preparing policies and guidelines for any kind of industries. - Expert in preparing Qualification, Validation, SOPs, URS, FAT etc. documents for any industry. - Expert in implementing and drafting plans for Preventive Maintenance, Breakdown Maintenance & Total Productive Maintenance. - Expert in Designing, Layout Preparation, Project Plan Preparation,Risk Management, & Procurement. - Expert in DMAIC, Six Sigma, QbD, TQM, QMS, WBS, CPM & PERT. CORE EXPERTISE : (1) Regulatory Compliance and CQV Expert Regulatory Guidelines Gaps Assessment, FDA, ICH, PIC/s, EU-GMP, cGMP Compliance, QMS Implementation, Risk Management, Change Management, Deviation & CAPA Management, FMEA, Site Master File, Validation Master Plan, URS, DQ, IQ, OQ, PQ, FAT, SAT, CSV, SOPs, GMP Auditing & Inspection Preparation. (2) Project Management Functions Green Filed & Brown Field Project Planning with QbD for Manufacturing Processes and Critical Utilities, Feasibility Assessment, Gantt Charting, Layout Designing, Equipment Capacity Planning, Process Flow Designing, Budgeting, Techno-Commercial Evaluation, Procurement, Construction, Installation, Commissioning, Qualification, Validation, Resource Allocation. (3) Engineering & Technical Functions Preventive & Breakdown Maintenance, Calibration, Equipment Qualifications, Process & System Validations, Process Optimization, Utility Systems (HVAC, Water System, WFI, PSG, Steam Boiler, Chiller, BMS, EMS etc.), Technical Troubleshooting, Compliance Documentation. (4) Construction & Facility Management Pharmaceutical Facility Construction, New Builds & Renovations of GxP Compliant facilities, Contractors and Vendor Management, Cleanroom Designs and Maintenance, ISO Classifications, HVAC Filtration Systems, Energy Efficiency, Waste Management, Energy. Project Management & CQV Expertise I have extensive experience leading Green Field and expansion projects in the pharmaceutical industry, specializing in planning, design, scheduling, and management of sterile formulations and fi ll fi nish projects. My expertise includes budgeting, cost estimation, tender preparation, vendor selection, procurement, cleanroom design, equipment capacity planning, and process engineering with CQV (Commissioning, Qualification and Validation) Expertise for Cleanrooms, Critical Utilities and Manufacturing Processes for Sterile formulations. I am skilled in installation, commissioning, URS, qualifications (DQ, IQ, OQ, PQ), SOP creation, FAT/SAT, CSV, SMF, and VMP preparation. Proficient in AutoCAD, I design layouts for man-material flows, P&IDs, flow charts, schematics, GA layouts, isometrics, area classifications, and pressure balancing diagrams for cleanrooms and HVAC systems. Pharmaceutical Technology and Regulatory Compliance I possess comprehensive expertise in the latest pharmaceutical manufacturing technologies and process systems with sterile formulation facilities, with deep knowledge of various clean and raw utility equipment, covering installation, commissioning, qualification