PROFESSIONAL EXPERIENCE
Professional with over 12 years of people management experience, 21 plus years experience in cGMP FDA Regulated Environments to include, 5 years in a Table Top Packaging Facility; 14 years in a Bulk API Pharmaceutical Facility and 14 years in Quality Assurance Roles. 13 years of Auditing experience to include FDA interaction, Raw Material and Component Non-conformance Review, 10 years Complaint Handling experience to include Finished Suspension Dosage, Remediation of/and Medical Device Reporting (MDR)/current knowledge of ISO 13485, ISO 9001, 21 CFR 803, 21 CFR 820, 21 CFR 210, 21 CFR 211, 21 CFR part 11, WHO Guidelines
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