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Pharmaceutical Quality Assurance
He possess thorough knowledge of GMP / GLP regulations like US FDA, WHO GMP, ICH, MHRA, ANVISA, requirements of cGMP documents (SOP’s/ Change controls/ Deviations) as per various regulatory agencies. He had actively participated in various international regulatory inspections (USFDA…
Process Automation: Process Control, Computer System Validation, Alarm Management, & Modeling
Expert served for several years as a major pharmaceutical company's chief Quality Assurance GMP/GLP computer validation auditor. He chaired the team that developed the company's first policy and guidelines regarding computer validation,- and served for several years as the company's…
Human Factors/Ergonomics, Systems Safety, Systems Engineering, Industrial Engineering, Design
Expert received his Bachelor of Science degree in Engineering (Astronautical) from Arizona State University in 1969. He next attended Central Missouri State University where he graduated in 1974 with a Master of Science degree with a field of specialization in…
Electronic Equipment, Microcontroller, DSP, Interfacing, VOIP, RF communication, Software (VB/ VC++)
Expert has developed many circuits based on analog/digital inputs and outputs. For example, an RTD changes its resistance depending upon the temperature. This resistor value is converted to a voltage signal in analog form and then sent to a comparator…
Process Engineering; Project Management-PRINCE2; Process Excellence; Pharma Solid Dosage scale-up
My diverse background includes: . 16+ years of executive management experience with Pharmaceutical and Consumer goods companies such as, Abbott, Pfizer Inc. Bristol-Myers Squibb, Johnson & Johnson, and Procter & Gamble. • Over 10 years experience in Pharmaceutical Development, Engineering…
Computer Forensics, Electronic Discovery, Internet Crimes and IP/Patent Analysis.
Expert has used BASIC on many computing platforms. He has designed, developed and implemented many batch programming languages. Representative computer science and engineering courses include: management information systems programming in Pascal, Cobol, Basic, Fortran, and C and C++ Programming. Engineering…
Semiconductor Equipment & Processes, Machine Vision, Laser Ablation, Control, Instrumentation
Expert managed 35 person organization covering sales, engineering, marketing, customer support, and manufacturing. He has performed market analysis, developed product specifications and ran engineering group to design wafer scanners. He als provided field sales support, and set up clean room…
Supplier Quality Assurance, Cost Improvement Projects, ISO 9001:2000 Quality Systems Management
- Expert audited suppliers to conformance with expected standards, such as TS 16949:2002 or ISO 9001:2000. An ISO standards based checklist was used; this provided quantitative scores for each category. Objective evidence and comments were compiled as the audits progressed.…
Industrial Hygiene, Occupational Health, Hazardous Materials Management, Emergency Response
He championed the implementation of a variety of strategies to reduce workplace accidents and injuries. Strategies included establishment of on site workplace health and safety teams. These teams included both management and labor employees who worked together to identify safety…
Outsourcing, Professional Services Firms
25+ years of outsourcing including manufacturing, Information Processing, Contract Programming, Application, Indian Offshore and Business Process Outsourcing experience. Market, Sold and Delivered many outsourcing deals. Today, Expert's on retainer with Employer (an investment firm) providing Outsourcing trends and insight to…