Contact Information

T:(905) 363-1182 x 270
F: (905) 542-7981

TF: 1 (877) 877-5152 x 270

2550 Argentia Rd • Suite 119 • Mississauga ON • L5N 5R1
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Lead Consultant

Colin Choo is a capable quality assurance professional, with more than 8 years of experience in the pharmaceutical industry. Colin is knowledgable and experienced in GMP regulations, validation, and quality control. Colin is a phenomenal communicator with strong leadership, project management, and organizational skills. Colin’s analytical skills, professional, and educational background add to the depth of the QCR team.

Skills & Highlights

Quality Assurance

  • Analyzed and assessed the impact of pharmacopeia monograph changes and revisions to company in-house testing procedures and product specifications
  • Directed appropriate actions and responses to ensure compliance of all company testing procedures and product specifications to Canada, US, Europe, and Australia market
  • Reviewed and approved laboratory testing results according to product specification
  • Investigated and evaluated non-conformances, deviations, and out of specification (OOS) / out of trend (OOT) results to determine root causes, risk assessment, impact on product quality, and Correction Action and Preventative Action (CAPA)
  • Initiated and implemented change control and CAPA in response to identified areas of improvement and deficiencies in the quality systems
  • Reviewed in depth and ensured all documentation including production batch records, laboratory data, records, and reports are accurate and compliant with current SOP, GLP, and GMP standards
  • Inspected and verified product packaging label according to client standard
  • Assisted in the release of raw materials, finished products, and packaging materials

Auditing

  • Conduct internal lab audits and gap analysis to ensure GMP/GLP compliance and audit-ready environment
  • Performed audit of third-party testing laboratories on behalf client’s supplier qualification

Validation

  • Performed and executed validation of new and revised analytical testing procedures (assay, degradation products) in accordance with ICP and regulatory requirements
  • Conducted routine cleaning validation of manufacturing equipment in accordance with established testing methods with a 1 day turn around time
  • Drafted and executed Installation, Operational, and Performance qualification (IQ/OQ/PQ) protocols for heating, ventilation, and air conditioning (HVAC), scales, cannabis processing equipment, packaging equipment, and fridges
  • Performed and executed qualification of facilities environmental monitoring and control such as warehouse, vaults, packaging room, and shipping/receiving area

Quality Control

  • Conducted qualitative and quantitative analytical testing on active pharmaceutical ingredients (API), excipients, raw materials, and finished drug products
  • Generate raw data and detail reports with high accuracy and short turn over time in compliance with GDP and GLP
  • Conducted and executed method verification of new and revised analytical testing methods

Technical Writing

  • Developed and revised standard operating procedures (SOP) and forms according to GMP standards for quality assurance, operations, health, and hygiene and incorporate into the quality manual
  • Prepared and issued protocols, reports and memorandum for API supplier evaluation, compendia method evaluation, testing procedures equivalency studies, deficiency responses, justifications, investigations, and root cause analysis to meet quality and regulatory requirements
  • Experienced in drafting, revising, and reviewing reports in regards to analytical laboratory method validation, deviations, temperature mapping studies, audits, and IQ/OQ/PQ

Training

  • Designed and led safety and compliance presentation in department meeting to promote workplace safety and GMP/GLP compliance
  • Trained laboratory analyst on analytical instruments and laboratory techniques such as HPLC, FTIR, UV, and automated titration

Computer Skills

  • Labware LIMS
  • Water Empower
  • SAP
  • Microsoft Office: Word, Excel, Powerpoint, Visio, Projects

Education

  • Project Management Certificate, Universtiy of Toronto, Toronto, ON
  • Bachelor of Science – Honours Biochemistry with Biotechnology Specialization, University of Waterloo, Waterloo, ON