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TVET Training on good manufacturing practices.
Expert has developed and implemented various good manufacturing practice training required for trainees undergoing vocational training in a Vocational Training Center. His areas of Training involves mainly in the attitudinal development in the area of Safety, Quality,Cost Reduction and Continual…
Procurement, Vendor Management, and Supplier Relationship Management
Expert's areas of thought leadership include Global and Regional Procurement: Category Management Source to Pay, Source to Contract, Requisition to Pay processes, Transformation, Change Management (greenfield and brownfield), Offshoring, Near-shoring, GBS (Global Business Services), and Shared Services Process modernization and…
Green and Clean Energy: Petrochemical, Refining, and Downstream Chemical and Utilities Sectors: Pre-commissioning, Commissioning, and Plant Startup
Executive summary: Expert has 17 years' experience in the petrochemical, refining, and downstream chemical and utilities sector. His experience includes pre-commissioning, commissioning, plant routine startup, shutdown, and emergency operations. His management roles include service as process trainer and process commissioning…
Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Cosmetic Manufacturing
• Successfully Handled a new range of Ayurvedic Manufacturing Factory from the scratch. Efficiently Managed a Factory with 400 man power. • Managed Five 3rd party manufacturing plants successfully. • Successfully Handled Flavour & Perfume Blending unit. • Setting up…
Equipment Validation
Experienced pharmaceutical process engineer with demonstrated ability in managing, supporting, and formulating in a dynamic environment. EQUIPMENT EXPERIENCE Ackley Imprinter Glatt - GPCG-1, GPCG Pro-5, VG Pro 65, Midi Glatt, VG-25, Glatt SKS-100 valves. Korsch - XL400WIP,…
Biotechnology, Pharmaceuticals,
Expert in Biopharmaceutical molecule development and licensure. Experience with top Biotech companies (BMS, sanofi, MedImmune, AZ, Adello, etc.). Designed successful Analytical strategy for 100s of IND and many BLA submissions in multiple countries. Expert in the following areas: Scientific writing…
Machine Tools, Heavy Equipment, and Aerospace Manufacturing Technologies
Expert began using CAM in its earliest stages, using Compact II and DataCut to created machine instructions for Numerically Controlled (NC) Machine Tools. He advanced to writing scripts and macros in Automatically Programmed Tools (APT) to perform machining functions around…
Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…