Audit records and facilities in reference to FDA, EPA, NRCand OSHA guidelines. Validate process, facility, equipment, test method, and systems (IQ,OQ, PQ). Advise on Quality Assurance / Validations needs. Implement QSR, QS, GMP, GLP, ISO 9000 into all phases of the company. Analyze product failure and product or process development. Research and assist in the development of microbiological, chemistry and other relevant means of monitoring processeses (SQC). Develop and implement Safety and Industrial Hygiene (per cal&fed OSHA.) Manage DHF (design history file), design transfer, and documentation system. Manage hazard analysis, fault tree analysis (FTA), and failure mode and effects analysis (FMEA). Develop laboratory facilities and testing procedures. Develop and implement a metrology and maintenance program using ANSI and ASTM regs. Develop, implement and manage an Information Systems program (i.e. small company networks, small to big company technical assistance and training). Develop, implement and manage Material Control system, using MRP (material requirements planning) and ERP (enterprise resource planning). Train personnel in QSR, GLP, GMP, ISO, OSHA, IH, and Information Systems. Establish an Ethernet LAN. Research and develop (feasibility) in pharmacology, chemistry, or devices. Analyze your testing/assaying or QC program, refine, and eliminate over/under-sampling. Refine your manufacturing process capability and establish alarms where needed, while cutting cost, effort, and unneeded surplus (SPC phase).
Audit records and facilities in reference to FDA, EPA, NRCand OSHA guidelines. Validate process, facility, equipment, test method, and systems (IQ,OQ, PQ). Advise on Quality Assurance / Validations needs. Implement QSR, QS, GMP, GLP, ISO 9000 into all phases of the company. Analyze product failure and product or process development. Research and assist in the development of microbiological, chemistry and other relevant means of monitoring processeses (SQC). Develop and implement Safety and Industrial Hygiene (per cal&fed OSHA.) Manage DHF (design history file), design transfer, and documentation system. Manage hazard analysis, fault tree analysis (FTA), and failure mode and effects analysis (FMEA). Develop laboratory facilities and testing procedures. Develop and implement a metrology and maintenance program using ANSI and ASTM regs. Develop, implement and manage an Information Systems program (i.e. small company networks, small to big company technical assistance and training). Develop, implement and manage Material Control system, using MRP (material requirements planning) and ERP (enterprise resource planning). Train personnel in QSR, GLP, GMP, ISO, OSHA, IH, and Information Systems. Establish an Ethernet LAN. Research and develop (feasibility) in pharmacology, chemistry, or devices. Analyze your testing/assaying or QC program, refine, and eliminate over/under-sampling. Refine your manufacturing process capability and establish alarms where needed, while cutting cost, effort, and unneeded surplus (SPC phase).