Instructor

• Oct 2022 - Present

Deputy Director, Operational Quality, Engineering Technical Services and QC Labs

• Dec 2021 - Present

Oversee team of Quality and Compliance managers within Engineering Technical Services (ETS) and Quality Control (QC) Labs, ensuring ongoing compliance with cGMP regulations, site and global policies, and inspection readiness. Achieved successful outcomes in over a dozen regulatory, corporate, and third-party inspections Established Deviation Review Boards achieving site leading deviation closure rates, and effective CAPA right first-time metrics. Successfully streamlined multiple processes, including vendor/third party service provider onboarding and management, maintenance work order completion & reconciliation, and raw material qualification and onboarding. Supported site in making quality decisions on numerous raw materials and finished product batch dispositions, Member of Site Change Control Review Board, Site Raw Materials team, and HADR/BPDR team Show less

Manager, Operational Quality QC Labs

• Apr 2019 - Dec 2021

• Oversee Operational Quality and Compliance within Quality Control (QC) Labs, ensuring ongoing compliance with company policies and GMP regulations, and assisting during regulatory audits.• Guide team of investigators on non-conformance events and OOS/OOT deviations.• Review and approve CAPAs, change controls, batch/testing records, SOP updates, protocols, test method and equipment validation reports.• Liaise with QC Operations team and Manufacturing Units to align on Quality and Compliance initiatives, and global policies.• Areas of oversight include: Chemical and microbiological testing labs, stability program, vivarium, LIMS, sample management and retention program, raw materials on-boarding, qualification and release.• Regular member of Site Change Control Review Board, Site Raw Materials Review team, HADR/BPDR review team. Show less

Lead Project Manager, Pharmaceutical Distribution & Sales Operations

• Sep 2017 - Feb 2019

• Managed and executed projects within Pharmaceutical Distribution and Sales Operations, with national scope across distribution sites and network of pharmacy and retails. • Collaborated nationally with cross functional teams and business units, in order to align and deliver successful projects, including operational system improvements, client on-boarding, transportation network optimizations, and national efficiency and alignment. Major Projects included: o Conceptualized and implemented company-wide national business continuity plan (BCP), including regional report structures and local crisis management teams. Established framework for regular upgrades and yearly compliance exercises. o Developed value added patient support and navigation programs for patients, pharmacists and doctors in order to increase patient adherence, satisfaction, and retention . Developments included web and telephone based reimbursement and drug coverage support , medication knowledge and disease management interactive tools, nurse and infusion clinic support. o Improved national transportation networks, including optimizing routes to increase efficiency and delivery schedules to customers. o Managed yearly flu vaccine national distribution program, coordinating with hospitals, pharmacies and ministry of health, ensuring compliance with cold chain requirements and injection site storage requirements. Show less

Manager, Site Quality Projects

• Mar 2016 - Sep 2017

• Accountable for managing site projects related to improving compliance in systems, processes and products. • Responsible for establishing project framework, creating project charters and protocols, and producing status reports and final summary reports.• Coordinating and delivering key project milestones, monitoring project status and performance indicators and gathering project documentation.• Tracking activities against project plan and regularly communicating with stakeholders.• Providing monthly update reports and presentations to senior management and leadership team.• Projects managed have included product remediation, risk assessments for systems and processes, PLC data integrity improvements, among others. Show less

Specialist, Manufacturing GMP Compliance

• Jun 2015 - Mar 2016

• Monitoring the manufacturing and packaging shop floor for adherence to internal SOPs during daily walk-through.• Planning and executing risk assessments to assess and re-mediate any gaps in processes and procedures to improve adherence to GMP regulations.• Developed Training programs utilizing adult learning principles. Delivering training to all site personnel on GMP Regulatory and Compliance topics including GMP refresher, Data Integrity, Gowning practices, and Quality awareness sessions.• Monitoring training gaps of company employees to ensure completion of all necessary GMP training.• Serving as quality representative on cross functional and cross site teams for improvement of quality systems, and serving as subject matter expert in support of departmental functions.•Member of Apotex Quality Ambassador program acting as liason between floor personnel and corporate quality culture team. Show less

Technician, New Product Launch Technical Operations

• May 2013 - Jun 2015

• Optimizing and validating new product launches using effective analytical skills, knowledge of scientific and technical principles, key process metrics, data and trend analysis, and investigation of out of trend results. • Applying problem solving skills and utilizing all available resources to correctly identify process and/or formulation deficiencies to develop robust and quality products meeting regulatory and quality specifications for human consumption.• Coordinating with multiple departments including QA, Regulatory Affairs, Validation and engineering in order to take new products from lab scale to mass production • Establishing process parameters to ensure product meets quality and regulatory specifications consistently in order to achieve high quality, trustworthy, robust products for human consumption• Monitoring process execution and supervision of production personnel during validation/launch batches• Preparing protocol, observation and summary reports. Show less

Technician, Environmental Sampling

• Jul 2011 - May 2013

• Responsible for performing and documenting testing of Purified Water samples, conducting various environmental monitoring activities, including collection and transport of samples, using various chemical, microbiological and instrumental techniques• Coordination with all departments in production, as well as lab personnel in order to complete scheduled sampling • Provide assistance to QA and engineering departments during renovation and new port/machine commission• Documentation within LIMS and SAP• Reviewing SOP and work instructions to improve efficiency Show less

Medical History Interviewer

• Jul 2010 - May 2013

• Responsible for obtaining confidential medical histories of applicants applying for various types of Life, Health and Disability Insurance. • for such companies as RBC, Co-operators, BMO, Primerica, Industrial Alliance and London Life • Documenting and transcribing medical information and following up with appropriate reflexive questions. • Enter case status updates into computer software and provide status updates to insurance client and underwriters. • Responsible for obtaining confidential medical histories of applicants applying for various types of Life, Health and Disability Insurance. • for such companies as RBC, Co-operators, BMO, Primerica, Industrial Alliance and London Life • Documenting and transcribing medical information and following up with appropriate reflexive questions. • Enter case status updates into computer software and provide status updates to insurance client and underwriters.