SUMMARY OF QUALIFICATIONS * Over twenty years of experience managing regulatory affairs (RA)/quality assurance (QA), quality control (QC)/research & development (R&D) departments in pharmaceutical, medical device and dietary supplement manufacturing industries. Implemented Quality Management Systems meeting domestic and international regulatory requirements and ISO registration. Reviewed pre-clinical, clinical and pharmacokinetic study protocols and reports. Directed Methods and Process Development, and Validations, QC Release Testing, Accelerated Stability and Compatibility Studies. Managed FDA & ISO audits, Supplier & Customer audits, internal & external audits. Implemented HACCP. FDA cGMP, EU Guidelines, ISO registration, NPA, NSF, ISO, Halal, Organic, and Kosher certifications. Management Representative for ISO registration. Validations (IQ/OQ/PQ). USP, EP, ADA, ASTM and FDA physical, chemical and microbiological methods

Highlights:

Companies I like:

Pharmaceutical, Medical Device, Biomedical

• Quality
• Quality Assurance
• Quality Control
• Manufacturing
• Regulatory Affairs
• Microbiological Testing
• Test
• ISO
• Pharmaceutical
• ADA