Mark Mountaniol Email & Phone Number

Los Angeles, Ca, Us

Markham, Ontario, Canada

Mississauga, Ontario, Canada

Main responsibilitiesManaged non-conformances (NCR) related to the manufacturing process, raw materials, and equipment.Executed Root Cause investigations Reviewed and approved Blueprints, Specifications, SOP’s, Work Instructions, and IQ/OQ Validation protocols and reports.Managed change controls (ECR/ECN) Performed supporting and monitoring of operations in clean rooms

Main responsibilitiesPrepared of the company for internal and external audits (CE & FDA)Conducted validation activities for equipment and software, including the writing of IQ/OQ protocols/reportsDesigned and executed Test Method Validation, including data analysis by utilizing Gage R&R and Attribute Agreement Analysis techniques Created and kept up-to-date technical documentation: Specifications, Design Verification Plans\Reports, URS, Functional Specifications, Validation Plans, IQ/OQ Protocols\Reports Planned and conducted products' verification & validation during development stages, including protocols, experiments, statistical data analysis, and reports

Main responsibilitiesConducted analytical studies for raw materials and drugs, using different techniques and advanced equipmentAnalyzed and documented studies' resultsConducted a variety of quality tests procedures over pharmaceutical products according to GMP rules and regulatory requirementsParticipated in preparations for external audits (FDA and CE)Operated equipment such as HPLC (Full Control in applications: Empower and Chromeleon), UV, and IRExecuted calibration of labs equipment and instruments.

Bachelor Of Science (B.Sc.), Advanced Materials Engineering

Quality Engineering (Certified By Asq)