Michael Tersigni Email & Phone Number

Canada

Canada

Brampton

Mississauga

Brampton, Ontario

Brampton, Ontario

Toronto

Contributions to continuous improvement initiatives include monitoring the impact of manufacturing and quality control corrective and preventative actions and the implementation of temperature monitoring protocols to identify product risk in the supply chain with emphasis on materials requiring special handlingManage GMP compliance evidence for foreign manufacturing sites, perform evaluation of third party labs and qualify API suppliers. Provide on-going oversight to ISO:13485 quality… Show more Contributions to continuous improvement initiatives include monitoring the impact of manufacturing and quality control corrective and preventative actions and the implementation of temperature monitoring protocols to identify product risk in the supply chain with emphasis on materials requiring special handlingManage GMP compliance evidence for foreign manufacturing sites, perform evaluation of third party labs and qualify API suppliers. Provide on-going oversight to ISO:13485 quality systems expansion for Class 2 and Class 3 Medical Devices. Assess CMC data in support of ANDS's for parenteral dosage forms and secure timely market entry by achieving technical transfers, approval of prescribing information and review promotional materials for regulatory compliance. Enhanced quality assurance functions by introducing comprehensive quality and compliance checklists for on-site supplier evaluations, implemented templates for generating detailed annual product quality reviews and detailed stability trend analysis. Show less

Mississauga, Ontario

Consultant in a full service boutique firm where I successfully gained project management skills to secure marketing authorization for category IV DIN products, medical devices and NHP’s while enforcing GMP compliance for multiple clients. Realized market entry by executing ICH compliant stability programs, auditing validation and product development packages, creating labelling material for multiple jurisdictions and performing formulation reviews for Health Canada and Environment… Show more Consultant in a full service boutique firm where I successfully gained project management skills to secure marketing authorization for category IV DIN products, medical devices and NHP’s while enforcing GMP compliance for multiple clients. Realized market entry by executing ICH compliant stability programs, auditing validation and product development packages, creating labelling material for multiple jurisdictions and performing formulation reviews for Health Canada and Environment Canada compliance.Acted as lead auditor in self inspections and assisted with comprehensive compliance evaluations of third party laboratories and contract manufacturers. Hosted 1 Health Canada GMP audit and assisted in 3 additional GMP inspections. Show less

Brampton

Staff supervisor in a fast paced, customer oriented environment

Toronto, Canada Area

Managed inventory and scheduled deliveries for 40 SKUs to 6 purveyors in the downtown Toronto area.

Bachelor Of Science (B.Sc.), Biological And Physical Sciences

Activities and Societies: Lab assisstant (volunteer) Core curriculum: Biochemistry, Molecular Genetics and Analytical Chemistry. Gained.

Certificate, Regulatory Affairs And Quality Operations (Co-Op)

Core Curriculum: Regulatory Affairs, Quality Assurance, Product Formulation, Biotechnology, Pharmacoeconomics and Technical Writing..