Description
Accomplishments * Reconstructed and aligned the Quality System of the firm to meet compliance with ISO 9001 and FDA regulations. * Implemented systems and processes to obtained Organic Certifications for the firm. * Written and performed several validations for companies including IQ, OQ, and PQ of pharmaceutical water systems, manufacturing, packaging and laboratory equipment. * Successfully directed multiple departments to meet company objectives. (Quality, Regulatory, R&D, Warehouse) * Created and implemented a certification training program for quality personnel. * Reconstructed and aligned the Quality System of a site to be in compliance with Health Canada regulations and achieved approval by the Canadian Inspectorate. * Supported FDA and global regulatory inspections in various functional roles. * Developed a vendor certification program for suppliers. * Performed over 40 compliance and Quality System audits for contract manufacturers and suppliers. * Generated a Quality Agreements to be implemented for all North American Health and Personal Care Contract Manufacturers. * Implemented a risk based supplier evaluation program for new and existing suppliers. * Reduced excess inspections through a continuous improvement Six Sigma project * Created and implemented a certification training program for quality inspectors.
Accomplishments
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