Jason Cheung

• Maintain the quality management system for clients (Stability, Change Controls, Product Release, Deviations, CAPAs, APQRs, Returns/Recalls, Product Complaints) • Assure all manufacturing processes, lab analysis and relevant quality activities are in conformance with Canadian GMPs and regulatory filings • Assure that the GMP related documentation is in conformance with client procedures • Support submission activities and coordinate launches as they relate to quality • Support vendor qualification programs by conducting audits (on-site or virtual) on behalf of clients • Conduct and facilitate audits and self-inspections on behalf of clients o Host and assist in Health Canada GMP audits o Manufacturing, packaging sites (including importers/distributors) o Self-inspections • Manage the client Quality Dossiers, including API specifications, analytical methods, FP specifications, test methods, analytical validation, process validation, stability, etc. • Maintain stability programs and annual confirmatory testing for clients • Conduct annual product quality reviews (APQRs) • Manage change controls program • Create/write and reviewed Standard Operating Procedures (SOPs) on behalf of clients • Reviewed Nitrosamine risk assessments reports and assure evaluations meet current Health Canada requirements and guidelines documents

• Batch review and disposition (Full Release, Conditional Release, Quality Holds) of all imported product types (DIN, NHP, Medical Device, Biologics, Radiology, Animal Health) in accordance with Bayer’s global specifications and Health Canada regulations • Coordinated and prioritized of batch release with internal/external stakeholders o Supply Chain, Warehouse, Bayer global manufacturing sites, third party laboratories, external Contract Manufacturing Organizations (CMO) sites • Reviewed and approved deviations for Bayer Canada and external third party CMO sites with global oversight o Drive timely resolutions of batch related issues: GMP/GDP, deviations, product quality issues • Performed audits - internal and/or external third-party packaging, manufacturing sites and warehousing o Generated audit reports and communicated observations and recommendations • Lead the QA Release Team in coordinating product releases and problem-solving quality related issues • Managed and completed projects which impact business o Audit Readiness - Data Integrity, Review of quality documentation/Batch Records o Product launch activities  Consumer Health division (Merck acquisition), Pharma division (Xarelto, Special Access Programs) • Implemented efficiency projects (Backorder Database, Procedural improvements, SAP Inspection Plans) • Maintained and improved key performance indicators (KPIs) for Product release turn-around times, Deviations) • Revised and maintained relevant Standard Operating Procedures (SOPs) • Initiated Change Control Documents (CCDs) and deviations and managed the completion of assigned action items • Supported GMP compliance, data integrity and continuous improvement within QA department • Key User for SAP and electronic systems administrator (user access, system changes, module implementation, annual validation) • Trained and coached Quality Associates and management teams

• Performed sampling and inspection activities on bulk, semi-finished and finished products • Conducted analytical testing for finished products (Quantitative and Qualitative) • Inspected finished packaging components and verify product quality documents (Certificate of Analysis, Batch Certificates, Certificate of Manufacture) against approved in-house release and/or compendial specifications • Initiated deviations and collaborated with key stakeholders, third parties and investigation team to resolve quality-related issues • Assisted in identifying corrective action preventative actions (CAPAs) • Managed the Stability and Annual Confirmatory testing program and coordinated sending samples for testing with Bayer global sites and/or external third-party laboratories

• Tested incoming starting materials and bulk drug products in accordance with company policies, procedures and GMP/GDP practices o Wet chemistry testing excipients and on packaging components o Identification testing on excipients and packaging components using Infrared, Near Infrared and Ultraviolet-visible Spectroscopy o Physical Identification of labelling materials and bulk drugs products o Document Reviewer (Analytical Data, Manufacturer/In-house Certificate of Analysis)

• Sampled and inspected incoming starting materials (APIs, excipients, packaging components), intermediates, bulk drugs and finished products in accordance with regulations and company policies, procedures and practices • Acceptable Quality Limit (AQL) inspection performed on bulk drugs, finished products and packaging components • Administer Retention Program o Annual inspection for starting materials, intermediates, bulk drugs and finished products o Collected retention samples and allocating to areas designated by the Retention Program