Wesley Paul

Quality Control & Laboratory Manager Designate @Ax Pharmaceutical Corp

Concord, ON, CA

Assisted in the set-up, development and regulatory licensing of a fully functional Health Canada and FDA accredited Quality Control Laboratory – designed for internal and external testing- Directly involved in the planning and designed of the quality control laboratory including the development of GLP training programs, waste management program, health and safety programs, facility temperature monitoring programs, glassware cleaning validation and stability study programs for select APIs.• Supervised safe operation of the Quality Control Lab and compliance with cGMP requirements daily.• Scheduled and coordinated routine and non-routine laboratory analysis including ID testing for release, stability studies and Cleaning Validation• Conducted LIRs, designed CAPAs and Change Controls for Laboratory Investigation• Assisted in the design and development of Quality Control Lab GMP training programs for new employee and routine training• Conducted routine SOP training for lab personal and created individual and class training records.• Assisted the design of protocols based on USP requirement for API Method Validation, Raw Material ID Testing, stability studies and environmental monitoring for GMP facilities.• Report Writing – completed several analytical reports for Method Validation and approved QC testing anddesigned reporting templates for routine QC and stability testing.• Designed and implemented cleaning validation programs, including glassware cleaning in QC laboratory and ISO 7 Cleanrooms.• Created and managed Health Canada and FDA compliant Inventory Spreadsheets.• Interpreted analytical data and provided understanding of information collected.• Provided analytical and technical support to Quality Control Chemists, Quality Assurance, and production departments.• QPIC for Controlled Substance – monthly reporting of controlled substance lab usage to QA Director for Health Canada.