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Steel Melting Techniques with Secondary Refining Metallurgy/Castings, Forgings
He is having expertise in manufacturing of steel in electric arc furnace through vacuum metallurgy such as vacuum degassing. Well conversant with liquid metal handling and pouring to manufacture castings specilised in manufacture of turbine rotors and generator rotorsfor power…
Medical Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new product introductions. A committed professional…
Steel Tube Technology Management, QMS, EMS, OHSAS, TQM, Stretch Target Process/ Product Development
General: Proficiency in the primary areas A post graduate in Metallurgy ( univ gold Medalist) and an MBA with 37 years of primary expertise in the following major areas: 1. Quality Management, Quality Assurance 2. Product and process development 3.…
Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…
Development and Assurance of High-Assurance / Safety-Critical Software & Embedded Systems
Expert has substantial experience with software safety and reliability. Most of his career has been spent working with high-assurance systems and safety-critical software. He has developed software for commercial aviation systems, for medical devices, and for industrial controls and safety…
In-Process Analytical, cGMP Auditing, Polymer Characterization, Analytical Lab Design and Management
Expert has 32 years of industrial analytical chemistry experience. For the last 24 years of that period, he headed the analytical R&D organization of International Specialty Products, a $1.7B specialty chemical company (as of 2007). In his time heading that…
Equipment Design and Manufacturing Processes: Automated Machine, ATEX-CENELEC, and ISO Compliance
Expert managed and created the design and build of multiple machines and units used for paper converting, printing, plastics manufacture, packaging, food processing, aircraft components, vision inspection and material handling. He supervised electro/ mechanical design department, composed of engineers, designers,…
Engineering Systems, R&D, Infrastructure, Governance, Projects and Program Management, Risk Management
Expert began research in computational mechanics of fibre-reinforced composite materials through which he obtained his PhD. With this background, he explored other advanced materials like piezoelectrics. Piezoelectric materials are essential for the development of SAW sensors. Surface Acoustic Wave (SAW)…
Pharmaceutical, Nutraceutical & Cosmetic Manufacturing
Expert has extensive experience with the Pharmaceutical, Dietary Supplement and Cosmetic manufacturing processes. Expert has been most efficient in providing compliance, process optimization and cost control guidelines through documented implementation. Working on a contractual basis, Expert can audit, recommend and…
Food Chemistry, Sensory Evaluation, Food Microbiology, Laboratories Accreditation, Quality Systems
Expert has several years of professional experience in Food Analysis, Food Chemistry, Food Microbiology, Quality Assurance of Food Microbiological and Chemical Laboratories, Quality Assurance of Mycotoxins Analysis Laboratories, Quality Assurance of Sensory Analysis Laboratories, including extensive work in application of…