Kamlesh Mistry Email & Phone Number

Toronto, ON, CA

Davie, Florida, United States

• Led a team of Quality Associates ensuring cGMP compliance as per FDA guidelines
• Oversaw the Internal Audit, Annual Quality Review of processes and Recall program
• Authored Standard Operating Procedures (SOPs) as per updated FDA and ICH guidelines for cGMP compliance
• Performed routine, refresher and annual cGMP training
• Qualified and maintained manufacturer, supplier and third-party lab testing facilities
• Reviewed and approved In-house Identity testing and third-party lab testing results for Active Pharmaceutical Ingredients

Toronto, Ontario, Canada

• Supervised a team of Quality Associates and assigned daily tasks ensuring cGMP compliance as per FDA guidelines
• Assigned activities and oversaw the completion of Internal Audit and Annual Quality Review of processes
• Authored and updated Standard Operating Procedures (SOPs) ensuring cGMP compliance as per updated FDA and ICH guidelines
• Performed annual cGMP training program
• Maintained manufacturer/supplier and third-party lab testing qualification documentation
• Reviewed and approved In-house Identity testing and third-party lab testing results

Toronto, Canada Area

• Authored and reviewed Standard Operating Procedures (SOPs) ensuring cGMP compliance as per FDA and Health Canada guidelines and monitored departmental training program
• Performed commissioning activities FATs (Facility Acceptance Test) and SATs (Site Acceptance Test) for environmentally controlled equipment (fridges, freezers and inventory room)
• Authored and executed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation documents for GMP equipment and facilities.
• Performed and executed temperature/humidity mapping study and reviewed weekly temperature monitoring reports of site facilities and equipment’s (fridge and freezers)
• Gathered and reviewed supplier/manufacturer documentation for cGMP compliance
• Conducted investigations for deviations, performed root cause analysis, assigned Corrective Actions Preventative Actions (CAPAs) and maintained Change Control Program

Toronto, Canada Area

• Received incoming product shipments, prepared product Certificate of Analysis (COA), relabeled products and completed batch documentation for approval to Quality Director
• Prepared invoices, organized and tracked products shipments also open sales order
• Reconciled monthly inventory locally and for distribution partners in the USA
• Designated as document coordinator during Health Canada Inspection (2017)

Toronto, Canada Area

• Synthesis and characterization of sulfonamide based antimicrobials coatings for treatment on various surfaces (textiles, plastics, and metals).
• Analysis and interpretation of compounds using NMR spectroscopy and Mass spectroscopy.
• Formulation development for surface treatment and industry scale production.
• Ensure safety of undergraduate assistants and working place by employing GLP.

Toronto, Canada Area

• Prepared lectures and organized laboratory activities for large groups of undergraduate students in a laboratory setting.
• Instructed and supervised experiments ensuring safety practices and procedures.
• Facilitated discussions during tutorials to ensure understanding of key concepts.
• Provide training on various instruments used in laboratory setting.
• Maintained equipment for student use.
• Developed tutorials and quizzes for a general chemistry course.

• Assisted senior Ph. D. candidate in running experiments, analysis, and documentation of results.
• Aid in synthesis and characterization of novel antimicrobial compounds.
• Maintained ordering and inventory of reagents required for experiments.

Toronto, Canada Area

Teaching Assistant For CHY 102- Preparation of tutorial lectures and quizzes.- Meet and advice students upon request.- Grading, documentation and submission of final grades.

Toronto, Canada Area

• Conducted research and developed quaternary ammonium containing antimicrobial compounds.
• Developed fluorescent tags for detection of coated surfaces.
• Analyzed compounds using NMR, UV/VIS, and Mass spectroscopy.

Master Of Science (Msc), Molecular Science

Bachelor Of Science (B.Sc.), Chemistry

Education record

Education record