Mathieu Champagne
Mathieu Champagne
Driving License
Lévis (G7A 2R4) Canada (Québec)
Professional Status
Available soon
Available
About Me
I want to be part of a company that has a real impact on people's lives. I love health sciences especially biomedical research as well as pharmaceutical and biotechnology fields. Quality assurance and quality control are facets of the industry that fascinate me. I am honest, hard-working, punctual, versatile and able to work in a team. I am bilingual for French and English and have a basic knowledge of Spanish. In addition to having great ambitions, I am always looking to do quality work and exceed expectations.
Quality Assurance Specialist
GlaxoSmithKline
April 2019
to September 2019
Temporary Replacement
Quebec City
Canada - Québec
- Ensure that all product manufacturing operations and analyzes are performed in accordance with applicable licenses, regulations and customer expectations
- Revise all GMP (Good Manufacturing Practices) documentation attesting that products have been manufactured and that production, laboratory and analytical equipment have been validated in accordance with established standards while respecting release schedules
- Verify and approve all production records and associated documentation from issue to release
- Propose and authorize the release or rejection of products by preparing relevant documentation. Identify, in the production area, the status of the products. Process the returns of the products in the ERP system (e.g.: MSSS, GSK)
- Participate in audits and response to observations
- Act as a resource person and provide coaching support to other departments on the operation of the various GMP systems included in the annual quality review (e.g., deviations, RPC)
- Write, verify and send official documentation to government authorities and other GSK sites according to specific requests from different markets. Review regulatory submissions and provide information as required
- Execute the site KPIs and the quarterly review of deviations
- Review the documentation related to the quality review by obtaining information from the various departments (e.g.: production files, quality systems, process validation), compile data and carry out trend monitoring
- Coordinate and modify spec sheets. Conduct product inventory
- Participate, revise, or complete the writing of various GMP documents
- Support the maintenance of Quality Systems policies and procedures
- Assist with oversight of the deviation/CAPA programs
- Review and approve deviations and CAPAs
- Conduct timely Quality review of associated data, including data utilized to support lot release, to meet business and operations requirements, and to ensure data meets the industry requirements for data integrity
- Perform GMP internal audits and monitor compliance
- Ensure that procedures are being followed as outlined under FDA and the Quality System requirements
- Represent department in cross-functional teams, projects and GXP-related problem resolution
- Review and approval of change controls
- Provide on the floor QA oversight and support to ensure compliance of GMP activities throughout the site
- Elevate to supervisor when non-conformances are identified as outlined per applicable procedures. Serve as a resource for compliance and corrections
- Ensure documentation is recorded in accordance with ALCOA principles
- Perform AQL particle inspection of in-process product vials prior to packaging
- Provide floor support for GMP activities
- Review batch documentation
