Patsy Boudreault Email & Phone Number

Montreal, Qc, Ca

Blainville, Québec, Canada

Blainville

Mont-St-Hilaire

Manage a team responsible of the release of finished products produced internally or by subcontractors as well as all related raw materials, printed and non printed components. Review and approval of process validation, cleaning validation, production masters, product quality complaints, investigations, change controls, annual product reviews, SOPs and CAPAs for these products and processes. Management of the continuous stability program, and approval of QC related events (LIR, deviations… Show more Manage a team responsible of the release of finished products produced internally or by subcontractors as well as all related raw materials, printed and non printed components. Review and approval of process validation, cleaning validation, production masters, product quality complaints, investigations, change controls, annual product reviews, SOPs and CAPAs for these products and processes. Management of the continuous stability program, and approval of QC related events (LIR, deviations, etc.) from internal and external laboratories. Ensure initial and continuous training for employees under my responsibility. Show less

Laval

Manage a team responsible for the various quality systems within the company in accordance with predefined objectives, including Quality Control, Stability, Compliance and Quality Assurance. Prepare and facilitate the Quarterly Management Review (QMR). Approve documents and reports related to my line of business.

Région De Montréal, Canada

Manage Quality System's related processes according to predifined objectives like Change Controls, CAPAs, Annual Product Reviews, GMP training & SOPs.

Manage the release of bulks and finished products received from subcontractors in accordance with predefined objectives. Manage the revision and approval of validation protocols & reports, production masters, new product launch, complaints handling, investigations, inspection and sampling for these products. Ensure initial and continuous training for employees under my responsibility.

Manage the revision of completed MBRs for the release of finished products on the market. Coordinate the release of raw materials, packaging components and printed materials according to the production schedule. Manage the post market stability program in accordance with the GMPs in order to assign shelf lifes for finished products. Manage storage and transportation requirements for finished products according to the GUIDE-0069.

Manage the pre and post market stability programs in accordance with the GMPs. Define and establish the priorities, plan and coordinate activities related to stability testing. Revise and approve investigation reports for OOS or OOT results. Revise and approve reports for end of studies and shelf life extension purpose.

Coordinate the post market stability program in accordance with the GMPs. Plan and establish priorities related to stability sampling and testing. Create stability programs for new studies and approve results for each time point. Investigate OOS or OOT when applicable. Perform stability reports at the end of studies and for shelf life extension purpose. Revise and approve annual stability reports received from third parties.

Review and approve analytical raw data, standardization and calibration reports from the quality control laboratory related to the testing of raw materials, finished products and stabilities.

Coordinate the planning of raw materials testing within the quality control laboratory. Perform analytical testing for raw materials and finished products. Maintain analytical specifications and methods according to current versions of related Pharmacopeias. Coordinate the post market stability program in regard to the pull out schedule and data recording. Revise completed MBRs for finished products release purpose. Perform line clearance inspections within the manufacturing and packaging… Show more Coordinate the planning of raw materials testing within the quality control laboratory. Perform analytical testing for raw materials and finished products. Maintain analytical specifications and methods according to current versions of related Pharmacopeias. Coordinate the post market stability program in regard to the pull out schedule and data recording. Revise completed MBRs for finished products release purpose. Perform line clearance inspections within the manufacturing and packaging areas. Show less

B.Sc., Chimie

Membre de l'Ordre des Chimistes du Québec

Dec, Chimie Analytique