Day work schedule Monday to Friday

Benefits of working at Pharmascience:

Annual bonus Internal referral program of up to $3,000 Vacation and floating vacations upon hiring Group insurance coverage as of day 1, including telemedicine Competitive pension plan with employer contribution as of day 1 Employee assistance program Ongoing training offered Stimulating and collaborative work environment On-site parking Gym

The QA Specialist reviews, approves, and releases incoming materials (raw materials, components and consumables), as well as the release of intermediate products (semi-finished) and finished products packaged at PMS or in subcontracting. In addition, the QA specialist provides support for the various operational activities of the Production, Validation, and Technology Transfer (TT) sectors. Reporting to the Manager, Quality Assurance, you will be responsible for ensuring the review and accuracy of information in production and packaging records, as well as all other documents related to OSD and Injectables production on the Candiac site.

Responsibilities:

Review and Approve the executed product sheets and all documentation relating to the various stages of manufacturing and/or packaging of semi-finished products and finished OSD and Injectable products, ensuring compliance with PMS and GMP requirements. Review and Approve receiving and inspection records and all documentation relating to inputs (raw materials, printed/non-printed components and process consumables) ensuring compliance with PMS and GMP requirements. Follow up with the various stakeholders when a file does not meet the requirements (so that measures can be taken). Release batches of products and inputs - for commercial or development use - by making the decision / status change in the SAP system. Issue the Manufacturing Certificate when required. Share batch release documentation with internal/external customers and make sure to answer their questions if necessary. Prepare and assemble files for digitization and archiving. Keep the various tools / tracking files of the team up to date. Manage communications received via the QA Operations group email inbox Initiate an investigation following the discovery of a quality incident. Participate/support regulatory and customer audits. Participate in various projects that aim to support production activities, plant compliance or the optimization of procedures/processes. Support production and floor presence. Prepare documentation for bioequivalence studies and clinical studies. Review and Approve manufacturing master documents (OSD and Injectables) and subcontractor master documents as needed. Review and Approve specific documents (protocols, reports, etc.) related to Production, R&D, TT or Process Validation activities, etc. as required. Review and approve equipment validation documents, as required. Review and Approve the BOM (Bill of Material) of commercial products in SAP. Write/review/comment departmental procedures. Conduct training activities with QA or Production colleagues. Use various computer systems (SAP, LIMS, Trackwise, DMS, LMS) and sharing tools (Teams, Sharepoint) and databases as part of his work. Support all other activities related to his duties

Skills, Knowledge and Abilities:

Knowledge of Canadian, European, and American GMPs Knowledge of good documentary practices (and ALCOA+ principles Sens of observation Thoroughness, rigor and attention to detail. Ability to write and interpret technical documents Excellent quality of verbal and written communications between the various stakeholders both internal and external to the Company Excellent planning and organizational skills Ability to manage several files simultaneously and to prioritize Excellent ability to work alone and in a team Ability to identify and solve problems Good adaptability in a changing environment Speed of execution when required and job well done Works under minimal supervision Mastery of software from the Microsoft Office suite, SAP, LIMS, Trackwise, DMS and LMS, as well as collaboration tools (Teams and Sharepoint Bilingualism (French/English) oral and written

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