Clara Tran Email & Phone Number

Canada

- Serve as a mentor to Quality Site Specialists (QSS) by providing expertise and exhibiting leadership in Quality initiatives.- National communication of regulatory requirements and/or changes and works closely with QSSs to ensure proper dissemination to distribution centres.- Create and dispense training material on Quality topics, as required.- Lead and/or support development and implementation of quality projects.- Collect, compile, and analyze quality data to identify areas for improvement.- Evaluate adequacy of quality assurance standards at a regional and/or national level.- Review the implementation and efficiency of quality and inspection systems/tools.- Support national and corporate-level investigations and action plan development.- Create, review and approve Quality documentation.- Support tracking and implementation of CSV-related projects and tasks across multiplebusiness units.- Coordinate activities with CSV project teams, including external consultants and servicesuppliers.- Maintain key quality metrics at a regional and/or national level.- Prepare reports to communicate outcomes of quality activities.- Coordinate or support on-site audits conducted by external providers.- Evaluate audit findings, identify risks and implement appropriate corrective actions at aregional and/or national level.• Monitor risk management activities.• Assure ongoing compliance with quality and industry regulatory requirements.

Edmonton, Canada Area

- Plan and execute regulatory compliance in a distribution center (DC) by providing expertise and guidance in interpreting governmental regulations, guidelines, and internal policies related to wholesale and distribution of products.- Ensure compliance of the Quality System, including but not limited to Change Controls, Deviations, Recalls, Returns and Customer Complaints. Ensures and enforces Good Documentation Practices on all applicable documents relating to GMPs.- Communicate and summarize compliance performance and results of the DC to the DCM and Quality & Compliance Manager.- Responsible for training of DC management, warehouse employees, customer service, and returns personnel on SOPs and GMP-related topics.- Manage the local DC self-inspection program including auditing and performing the associated report according to established schedules and timelines. Initial and follow up on corrective actions to be taken in areas of non-compliance and develop preventative actions in conjunction with the Corporate Quality and Compliance Department.- Participate in Health Canada and vendor audits. Prepare audit responses in a timely manner, ensure observations are addressed and closed in a reasonable timeframe and follow up if not received in that timeframe.- Participate in writing and reviewing of SOPs. Ensure controlled maintenance of up-to-date documentation and adequate implementation of SOPs for all operational activities in the DC.- Ensure McKesson's temperature monitoring system is functional at all times and that the Temperature Profiling system is utilized according to SOPs.- Where necessary, contact manufacturers to obtain guidance on product integrity in case of deviation or any instance where product safety and/or quality may be compromised. - Ensure qualification and validation of thermal equipment containing drug products and accurate warehouse temperature mapping is performed in a timely manner.

41 Broadway Blvd, Sherwood Park, Ab T8H 2C1

- Ensured that GMPs, HACCP procedures, and CFIA regulations were met in a food processing facility producing frozen pastas, cabbage rolls, and sauces for both retail and food service purposes.- Monitored employees performing processing, cooking, cooling, packaging, sanitation, and shipping/receiving/storage procedures to ensure that processes were completed according to company policies.- Created, completed, verified, and filed large volumes of records (i.e. production records) on a daily basis.- Liaised regularly with CFIA Inspectors, other company departments, as well as third party contractors both in-person and via telephone and email.- Applied creative problem-solving skills to effectively address in-plant issues in a timely and efficient manner.- Prepared training documents and administered periodic training sessions for all plant employees. - Acted as the first point of contact on-site for all quality assurance and food safety concerns.- Applied training and educational background in food science to maintain and develop quality assurance programs and policies.- Performed daily pre-operational inspections to ensure that the premises and all equipment were in a condition acceptable for production.