Developed appropriate internal processes for a structured approach to the creation of validation documents (DQ/IQ/OQ/PQ/PV & PPQ) to FDA & Heath Canada standards.Developed effective systems to monitor progress of all validation activities and contingency plans as required using a “Product Life-Cycle” approach.Worked closely with R&D, Engineering, IT and Operations, to develop effective design spaces for critical parameters for required processes.Implemented statistically-based methods to identify areas of opportunity for process improvements.Trained staff on validation principles and related documentation.Performed Temperature Mapping and Humidity Qualification (OQ/PQ) for Refrigerators, Autoclaves and Stability Chambers across various set-points and temperature ranges.Reviewed batch records, track stability data and release bulk and packaged product for solid dosage pharmaceutical manufactures.Prepared Annual Product Quality Reviews (APQRs) & (APRs) for various Private Label Over-The-Counter (OTC) drug products.Prepared and revise SOPs and Preventative Maintenance Schedules for facilities and equipment as required.Delivered annual GMP refresher training for all departments.

Assisted the Quality Assurance Department with the review and closure activities of approximately 3,000 customer complaints.Assisted the CQV document preparation / CQ Methods team with the drafting of Start-up Shakedown (SU/SD), Installation Verification (IV) and Operational Verification (OV) protocols.Execution of Start-up Shakedown (SU/SD), Installation Verification (IV) and Operational Verification (OV) protocols to confirm the installation of systems as per cGMP guidelines and User Requirement Specifications (URS).Execution of the Requirement Testing Matrix (RTM) and Commissioning Test Plans (CTP) required for GxP and Non-GxP systems confirming the commissioning of equipment.

Ensured that the Validation Master Plan (VMP) is complete, accurate and current.Developed appropriate internal processes for a structured approach to the creation of validation documents (DQ/IQ/OQ/PQ/PV & PPQ) to FDA & Heath Canada standards.Developed effective systems to monitor progress of all validation activities and contingency plans as required using a “Product Life-Cycle” approach.Worked closely with R&D, Engineering, IT and Operations, to develop effective design spaces for critical parameters for required processes.Implemented statistically-based methods to identify areas of opportunity for process improvements.Trained staff on validation principles and related documentation.Performed Temperature Mapping and Humidity Qualification (OQ/PQ) for Refrigerators, Autoclaves and Stability Chambers across various set-points and temperature ranges.Drafted SCADA System Back-up computer validation IQ/OQ/PQ and PPQ protocols in the Manufacturing and laboratory environments.

Drafted and performed Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols to Health Canada standards on Packaging Line Equipment.Reviewed batch records, tracked stability data for the release of bulk, packaged and various Private Label OTC products.Prepared APQRs for Private Label OTC products.Prepared and revised SOPs and Preventative Maintenance Schedules for facilities and equipment as required.Delivered annual GMP refresher training for all departments.

Validation Consultant:Provided technical support to Validation and Product Development teams.Drafted IQ/OQ/PQ protocols to all standards.Performed Qualification (IQ/OQ) on refrigerators/cold rooms, Ultra Low Temperature freezers, and environmental chambers.Performed Temperature Mapping and Humidity Qualification (OQ/PQ) for Warehouse, Incubators and Stability Chambers across various set-point and temperature ranges.Addressed changes occurring during protocol execution and draft associated change control reports.Addressed non-conformances occurring during protocol execution and draft associated deviation reports.Quality Assurance/Quality Control Officer (QCO):Developed/revised SOPs and documentation for drug, natural health products and medical device importers and distributors.Developed SOPs for Mutual Recognition Agreement (MRA), drug and natural health products importers, packagers and distributors.Reviewed batch records, track stability data and release of bulk and packaged product for solid dosage pharmaceutical manufacturers.Addressed non-conformance's and/or changes to process inefficiencies and draft associated deviation and/or change control reports.Delivered GMP Training

Executed and trained new team members in the formulation, blending and compressing of solid dose products through the use of Fluid Bed Granulation, and various tablet presses (Korsch, Fette & Hata).Executed and reviewed manufacturing orders through completing labour data collection and cycle time tracking documents accurately, and on time according to SOP and cGMP guidelines.Provided management with technical feedback on process and operational procedures to facilitate efficiency improvements to create a 50% increase in overall productivity.Provided technical support to the Validation and Product Development teams.