T: 905.363.1182 x.249
TF: 1.877.877.5152 x.249
2550 Argentia Road • Suite 119 • Mississauga ON • L5N 5R1
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Steven is an experienced quality assurance consultant for API, pharmaceutical and natural health products with a background in Chemistry. His experience with Good Manufacturing Practices (GMP) and Good Production Practices (GPP) has helped him fulfill a number of key quality processes, including development and deployment of site quality manuals, hosting Health Canada inspections, dispositioning product, investigating compliants and deviations, delivering GMP Training, preparing reports and Certificates of Analysis, and validating new methods. Along with his technical know-how, Steven also has strategic business experience, an added benfit to our clients.
Skills and Highlights, Large Compliance Projects
Quality Control (QCO)
- Hosted a Health Canada inspection for API importation
- Received, inspected and released all incoming material
- Consolidated and updated all product regulatory information
- Completed all customer QA reports and questionnaires
- Primary contact for investigating customer complaints, deviations and out of spec results for API and NHP ingredients
- Reviewed Annual Product Quality Reviews for pharmaceuticals
- Compiled and reviewed data for complaints, deviations, changes, validation, manufacturing, packaging, actives, raw materials, stability, analytical testing and critical in-process parameters
- Ensured compliance of processes with Good Manufacturing Practice (GMP)
- Provided GMP training for bulk API and NHP ingredient importing and distribution
- Issued official Certificates of Analysis based on testing results
- Provided QA support in reviewing cleaning, in-process control, stability, intermediate and raw material characterization test results for an API fabricator.
- Trended historical deviations over a three year period for an API fabricator
- Developed and validated new methods and techniques related to lab scale production and analysis
- Wrote protocols for the validation of equipment and computer systems
- packaging and sterilizing equipment.
- computerized Building Automation Systems.
- computerized production and inventory management software.
- client facing GxP websites for medical professionals.
- Reviewed Installation Qualification and Operational Qualification protocols pre and post execution.
- Executed re-qualification protocol for the packaging and sterilization equipment for surgical tools.
- Executed shipping study protocols for both summer and winter seasons.
- Performed Data Integrity assessment and Impact Risk Assessment for 25 computerized systems.
- Perforfmed production facility and laboratory design reviews for licenced cannabis producers.
- Updated, revised and approved regulatory documents pertaining to bulk API and NHP ingredients (eg. Specs, residual solvents, allergen report, etc.)
- Performed DEL maintenance annual activities
- Maintained adherance to Health Canada Bulletins
- QAR submissions for production and sale of medical cannabis.
- Performed GMP Gap Analysis of a licenced third party testing laboratory.
- Performed GMP Gap Analysis of a API Importer/Distributor
- Performed GMP Gap Analysis of a pharmaceutical fabricator’s in-house testing facilities
- Performed GPP Gap Analysis for a GMP licensed contract manufacturer
- Performed GPP Gap Analysis for a cannabis licence applicant
- Created, revised and approved numerous SOPs in a short time frame, in preparation for Health Canada audit
- API Importer/Wholesaler .
- Drug product Importer/Wholesaler
- Cannabis licenced producter
- Drafted, reviewed and revised client SOPs as part of a Health Canada audit remediation
Awards, Recognition and Achievements
- Nominated for SOGS teaching award, University of Westerm, London Ontario
- MSc. Chemistry, University of Western, London Ontario
- BSc. Honours Chemistry, University of Western, London Ontario
- BSc. Biochemistry and Chemistry, University of Western, London Ontario
- Working In A GMP Environment Certification, Pharmaceutical Sciences Group, Toronto Ontario
- Data Integrity Training - Q&C
- Audit Skills Course - Q&C
- Technical Writing Course - Q&C
- Deviation Handling and Investigations - Q&C
- Innovation Technology and Artificial Intelligence - Pharmaceutical Sciences Group - Q&C