Kevin Buchaly Email & Phone Number

Hamilton, On, Ca

Oakville, Ontario

Responsible for 20 people and the day to day processing operations of solid dosage, liquids and topicals manufacturing areasResponsible for organizing operations and personnel to ensure that manufacturing operations proceeded on schedule to meet demanding delivery requirements for clientsRequired to run operations to maximize output while minimizing overtime costsSOP and batch record documentation updatesParticipated in regulatory agency and customer auditsHandled personnel issues in a prompt and professional manner

Developed validation documents and procedures for a business entering the market as a supplier to the pharmaceutical/medical device industryWorked closely with customers to develop equipment validation documents (IQ/OQ/SOQ) for custom manufactured automation equipmentInvolved in the execution of equipment validation both as validation lead and providing support to customers executing validation protocolsProvided expertise for potential customers to discuss the validation capabilities of ATS as well as detailing individual requirements for each customerDeveloped training seminars to familiarize company personnel and customers with the requirements for 21CFR11 as well as provided expertise to customers to define their requirements for cGMP/GAMP compliance

Cambridge/Markham, Ontario

Developed SOPs for all areas of the company and IQ/OQ documents for process equipment and utilitiesParticipated in the inspection for approval for obtaining an Establishment License for the companyEnsured maintenance and equipment calibrations were completed as scheduled and maintained records of duties performedDeveloped master manufacturing and packaging documentsResponsible for day to day activities of the facility Located material suppliers and arranged the procurement of materialsCambridge site is dedicated to the production of solid dosage cephalosporin products

Etobicoke, Ontario

Reviewed completed batch documents from manufacturing and packaging operations, verified that discrepancies were investigated and resolved before releasing item to next stagePerformed daily inspections of production areas and ensured that GMP practices were being followedCollaborated with other departments as part of the continuous improvement initiativeInspected goods to determine whether they meet AQL (acceptable quality limits) Responsible for releasing products under SAP (Special Access Programme)

Rexdale, Ontario

Worked as part of team in a manufacturing environment to produce bulk pharmaceutical chemicalRequired to operate all stages of manufacturing processEnsured that technicians were properly trained and safety standards were maintainedDocumented process and ensured that product was manufactured according to GMP (Good Manufacturing Practice) guidelinesResponsible for writing and editing of Standard Operating Procedures used for training and setting company policiesManaged safety training