Chi Tran Email & Phone Number

Mississauga, Ontario, Canada

Lead CMOs to ensure regulatory compliance, maintain a high level of product quality, and drive continuous improvement initiatives. Responsibilities include overseeing pivotal launches, projects, and validation activities to enhance operational efficiency. Additionally, ensure robust change management, deviation investigation, and periodic review processes are in place to assure product quality.

Mississauga, Ontario, Canada

Developed and implemented practical and attainable policies and procedures, which ensured alignment with regulatory requirements, cGMP standards, and industry best practices. Efficiently managed document control, change management, and deviations. Successfully obtained the site MDEL and spearheaded efforts to implement an eQMS system.

Mississauga, Ontario, Canada

As a consultant, efficiently managed product release processes, document maintenance, and change control initiatives. Conducted thorough deviation investigations and provided expertise in SAP implementation. Successfully supported audits and inspections, ensuring compliance with Health Canada drugs and medical device requirements.

Mississauga, Ontario

Conducted product review and release, managed change controls, and hosted successful vendor audits, ensuring compliance with quality standards. Participated in SAP implementation as a quality subject matter expert, contributing to seamless integration of quality processes.

ensure GMP compliance and manage all related activities, including site registration renewals with Health Canada. Serve as the primary contact for audits, implementing corrective actions as needed. Coordinate with manufacturing sites to ensure GMP compliance, manage change control, and lead investigations and recalls when necessary.

Mississauga, Ontario, Canada

Managed regulatory submissions including FDA 510(k) and PMA Supplements, ensured compliance with strict timelines and quality standards, and communicated with regulatory authorities for efficient processing. Prepared SOPs, reviewed marketing materials for compliance, and monitored regulatory requirements for multiple countries. Provided guidance and solutions to internal departments on regulatory matters.

Third Party Products (F/T - Work exchange Program)Performed final release of third-party products, reviewed labels and batch documentation for received items, conducted investigations for product complaints, deviations, and out-of-specification results. Completed annual product reviews and communicated with suppliers to establish GMP agreements, streamline testing certificates, and conduct vendor reviews.

Solid Dosage Manufacturing (F/T)Investigated manufacturing and analytical deviations, prepared reports, and reviewed deviation trends. Conducted GMP compliance audits, reviewed documentation, and issued batch expiry dates. Released production batch documentation and collaborated with various departments to resolve quality issues.

Prepared Installation and Operation Qualification documents and process validation protocols for manufacturing processes and regulatory submissions. Managed validation samples, coordinated with the quality control laboratory, and generated reports from manufacturing and quality control data. Coordinated validation projects to ensure timely approval and adherence to deadlines.

Gastroenterology and Hepatology Department (F/T)Prepared clinical trial applications and amendments for Health Canada and local Research Ethics Boards. Negotiated trial budgets with sponsors, prepared informed consent forms, and recruited patients for studies. Managed clinical patient databases, conducted literature searches, and processed laboratory samples for storage and shipping.

Bachelor Of Science, Human Biology

Applied Arts And Technology, Pharmaceutical Quality Assurance And Regulatory Affairs

Regulatory Affairs and Quality Operations (Co-op) Post-Graduate Program Subjects studied include Food and Drugs Act, clinical research.