Description
Summary of qualifications Over 30 year's experience, this includes the following: * Instrumentation control system development and implementation. These include Process Control, PLC Programming, Water System, HVAC, Clean Room, Analytical instrumentation, Packaging Equipments, Waste treatment, Sterilizer, Compress Air and Steam Turbine Combined/Cogeration. * Write and execute test scripts Installation Qualification, Operation Qualification and Performance Qualification (IQ/OQ/PQ). * Perform Factory Acceptance Test (FAT) and Site Acceptance Test (SAT). * Validation of process/packaging equipment, Compress Air, computers software, HVAC/clean rooms, aseptic filling, solid dose and sterilization (Steam/Ethylene Oxide/Gamma). * Provide leadership and training in process validation, software validation, test method validation and data analysis. * Quality Assurance overseeing all FDA and ISO 13485 (Medical Device) compliance. * Perform instrument calibration per ISO/ANSI/NIST or any government regulation requirements. * Write all Standard Operation Procedure (SOP) used for Instrument Calibration, Maintenance, Packaging, Production, Process and Quality Assurance FDA/ISO. * Support all quality system activities leading to improve compliance with corporate policies, 21CFR820, ISO 9001, ISO 13485, ISO 14971, the Medical Device Directive, the Canadian Medical Regulation (CMDR) and other applicable regulatory agencies. * Insure that all projects are in compliance with GLP, QSR (including Design Controls), ISO or other applicable requirements. * Perform risk management assessment on all new and existing products. * Responsible for product packaging related to serialization and packaging 3D designed. *
Accomplishments
Highlights:
Keywords
