Samuel Mak Email & Phone Number

Toronto

Toronto, Canada Area

Toronto

Quality and Compliance

Toronto, Canada Area

Apollo Health & Beauty Care 2013 to 2014Quality Assurance Manager• Manage daily function of In-Process Line Auditors for line filling of packaged products• Resolve quality issues related to packaging activities with Line leaders and supervisors• Provide quality guidance to In-Process Line Auditors to resolve quality issues• Investigate and closure of Out of Specification reports and Provide products disposition recommendation to Senior Director • Manage Packaging Component Technicians for daily sampling, testing and release of primary, secondary and tertiary packaging components• Release and quarantine finished products in Syspro ERP system• Perform audit of suppliers, external laboratories and Third Party contractors• Participate and support in Health Canada, FDA and external client audits

Toronto, Canada Area

Sanofi PasteurManager, R &D Quality Assurance Compliance 2004 to 2013• Coordinated the investigation and closure of Quality Notification in Trackwise related production and QC testing of sterile clinical vaccines; this included tracking, resolution and making recommendations for product disposition • Follow-up on and close Corrective and Preventive Actions in Trackwise initiated by Process Development, and respective QC testing areas, as a result of Quality Notification • Tracking and resolution of change control to ensure closure on time. Made recommendations to department’s management for vaccines disposition in SAP• Reviewed SOP’s, mBPR’s and executed BPR’s detailing the manufacturing of sterile clinical vaccines; equipment operation, and test and quality procedures for compliance to cGXP requirements• Performed audits of sterile manufacturing facilities to ensure compliance with cGMP standards and corporate policies. Provided support in preparation for third party customer audits• Represented R&D QA on Research and Development working teams and provided direction on quality issues and regulatory compliance• Worked with Process Development and Industrial Operations on selection of raw materials to ensure GMP multi-compendial grade were utilized. Reviewed raw materials specifications and perform quality checks on raw materials/animal origin materials in SAP • Managed Third Party manufacturing sub-contractors for manufacturing of sterile clinical vaccines, and prepared Quality Technical Agreements with suppliers• Audited of Raw Materials suppliers for Industrial Operations and Research/Development departments• Investigated Cold Chain Breaks and provided sterile product disposition based on established stability data

Toronto, Canada Area

• Managed, Coordinated and approved raw materials and packaging component test results.• Initiated Raw Materials Process Improvement and provided resolution on process problems.• Organized and coordinated the Data Management of animal origin raw materials for new suppliers• Performed Business function decision, planning and capacity management in SAP ERP system• Managed the approval of raw materials and packaging component specifications.• Managed unionized staff for Raw Materials and Packaging Components for sampling, testing and release• Performed SAP transaction for raw materials and packaging components release and quarantine in SAP ERP system• Performed raw materials recipe planning and structure formation in SAP ERP system• Provided expertise advice on raw materials selection and qualification

Pickering

• Review and approve clinical SOP’s for clinical department. • Create R&D QA SOP’s for the Research department.• Internal audit of R&D activities• Work with Production Department for the storing of clinical trial materials• Certified as a QPIC backup for R&D

Toronto, Canada Area

• Performed QA release of Parke-Davies solid and liquid drug products and Warner Lambert Consumer Healthcare packaged products for markets distribution• Liaised with sub-contractors for Third Party manufacturing of GMP drug and consumer healthcare products• Reviewed and approved sub-contractors’ deviation reports, change controls, and method validations• Performed ID testing of Consumer Healthcare products for release• Coordinated with Global Technology Group for the development of Near-Infrared tests for Consumer Healthcare Identification testing• Provided recommendation to Senior Manager for Health Canada regulatory requirements for Consumer Healthcare products

Toronto, Canada Area

• Performed stability studies on new drug products (solid and liquid dosage) using techniques such as HPLC, GC, UV-Visible, Dissolution and Disintegration testing, Infrared spectrophotometer, wet chemical bench analysis• Participated in identification of new drug products with Product Development department for ANDA submission• Provided support to Regulatory Affairs for Abbreviated New Drug Application (ANDA) to FDA• Supported and participated in FDA drug Pre-approval Inspections• Performed laboratory deviation investigations for Out of Specification products and resolved testing related issues

Masters Of Science, Chemistry

M.Sc

B.Sc, Hon, Co-Op Applied Chemistry

Co-op degree and had a wide range work experience with employers such as National Defense, DuPont Co, Ontario Ministry of Environment.