In my current role I am proud to lead a comprehensive technical team supporting manufacturing throughout the supply chain. The Equipment Services department is comprised of three functional groups and 50 staff supporting the entire equipment lifecycle.

In this role I led a twelve member team of Validation Associates and Deployment Associates providing national support for the validation program as well as deployment of equipment throughout the Supply Chain. Scope of validation and equipment deployment support included the Testing, Component Manufacturing, Collections, Distribution, Logistics, Cord Blood, Stem Cells, Facilities and Equipment Services departments.Responsible for representing the national Supply Chain at the capital committee, overseeing equipment acquisition and budget for the Collections, Distribution, Logistics and Production departments.Managerial Responsibilities included:Developing managing departmental budgetInterviewing and hiring staffOverseeing staff developmentCoordinating project support and distributing workReviewing and approving expense reports for travelPerforming annual reviewsTechnical responsibilities include:Reviewing and ensuring the quality of validation documents generated by the team.Developing validation and implementation strategies. Assessing and reviewing validation assessments for new equipment, repairs and/or changes to existing equipment.Developing, refining and assessing the validation program. Oversight of the Supply Chain equipment acquisition and evergreen plan.

In this role I was responsible for the national validation program for the Canadian Blood Services defining and refining the program. In addition, I oversaw the management of the equipment fleet within the supply chain.Actively managing the ten member team of Validation Associates providing national support for the validation program. Scope of validation support includes the Testing, Component Manufacturing, Collections, Cord Blood, Stem Cells, Facilities and Equipment departments.Responsible for representing Supply Chain at the capital committee, overseeing equipment acquisition and budget for the Collections, Logistics and Production groups.Managerial Responsibilities include: - Developing managing departmental budget - Interviewing and hiring staff - Overseeing staff development - Coordinating project support and distributing work - Reviewing and approving expense reports for travel - Performing annual reviewsTechnical responsibilities include: - Reviewing and ensuring the quality of validation documents generated by the team - Developing validation and implementation strategies - Assessing and reviewing validation assessments for new equipment, repairs and/or changes to existing equipment - Developing, refining and assessing the validation program

Actively managed three team members providing validation support to the Donor Testing departments. Scope of validation support included the Transmissible Disease and Blood Group Serology Process groups, Laboratory Operations, and Equipment ServicesStaff support responsibilities include:Interviewing and hiring staffOverseeing and staff developmentCoordinating project support and distributing workReviewing and approving expense reports for travelPerforming annual reviewsReporting regularly to the Donor Testing Management TeamTechnical responsibilities include:Reviewing and ensuring the quality of validation documents generated by the teamDeveloping validation and implementation strategies Assessing and reviewing validation assessments for new equipment, repairs and/or changes to existing equipment Developing, refining and assessing the validation program within Donor Testing

Worked closely with the Quality assurance, Processing, Compression and Packaging groups to prepare and execute validation protocols in a full service contract manufacturing facility.Prepared and executed validation documentation for a wide variety of processing and packaging equipment.Oversaw testing, documented and reported results for process validations, which included all aspects of solid dose tablet formulation and manufacture.Oversaw testing, documented and reported results for packaging validations, including a wide variety of different packaging configurations including cartoned, boxed, bottled and blister packed products.Responsible for demonstrating through testing compliance to GMP and regulatory standards.Received training and experience working in high potency product manufacturing environments.Prepared and reported cleaning validation protocols demonstrating adequate removal of pharmaceutical residues and microbes.

Generated and executed validation documentation for a variety of different pharmaceutical and biologics manufacturers in project environments as an on-site consultantProvided validation oriented consulting services to several major pharmaceutical companies in Canada.Clients included: Aventis (Toronto), Celmed BioSciences (Montreal), Shire (Quebec) and MDS Nordion (Ottawa).Prepared and executed validation documents for manufacturing facility systems, automated packaging lines, building automation systems, central archiving systems, freezer monitoring and alarm software, freezers and others.Received formal training using Microsoft Word and Excel, Thermal Validation of fridges/freezers and autoclaves (Using Kaye 2000) and Site Acceptance Testing.

Generated and executed validation documentation for a variety of different pharmaceutical and biologics manufacturers in project environments as an on-site consultantPrepared and executed validation documentation for HPLCs, densitometers, fridges, freezers, water baths and capillary ion instruments (Wyeth).Assessed and prepared validation documentation for the facility information management systems (Cangene).Performed assessment for 21 CFR 11 compliance.Prepared and executed retrospective validation documentation for systems, including Filter Integrity Tester firmware and Product Release Quality Control Spreadsheets (Aventis)

Laboratory Technician (Validation), Maxxam Analytics Inc.Mississauga, ON — 1998-2001Hired initially as laboratory technician under a student summer contract and hired full time on graduation. Prepared and executed validation documentation ( IQ, OQ, PQ) for laboratory equipment and software including balances, centrifuges and freezer monitoring systems.Generated SOPs for equipment and software.Performed assessment for 21 CFR 11 compliance and prepared remediation plans.