As the QA Specialist - Third Party Reviewe, you will act as a compliance resource person to ensure the application of the GMPs as well as all Canadian & International regulatory requirements. You will actively participate in the various quality activities related to the release of products in compliance with marketing authorizations. You will coordinates communications and activities relating to quality and compliance aspects between Pharmascience, Subcontractors and Clients.
Responsibilities & Duties :
Review the documentation and approve or reject lots according to the established checklists
Perform lot status changes in SAP
Contribute in the implementation of the change actions related to the release.
Coordinate with the supply group to establish the priorities of the lots to release
Keep reference tables and other communication & priorization tools up to date.
Contribute effectively in various initiatives and projects with multidisciplinary teams.
Prepare Certificate of Manufacturing for products sold to external clients
Approve Quarantine Use authorizations
Contribute to the Change Control and CAPA processes with respect to release activities.
Skills, Knowledge & Abilities :
Minimum BA in science or related discipline or experience considered as equivalent.
Minimum 2 years’ experience in the pharmaceutical industry
Bilingual oral and written (English / French) as the incumbent will have to communicate with suppliers located outside the province of Quebec
Observation skills, thoroughness and rigor
Capacity to take decisions and to communicate them with tact and diplomacy
Facility to interact and excellent aptitude to communicate with people