Quality & Compliance/ Scientific Affairs Coordinator 1. Objective and Scope 1.1 To define the responsibilities of the Quality & Compliance/ Scientific Affairs Coordinator at Sunovion Pharmaceuticals Canada Inc. 2. Responsibility 2.1 As delegated by the Manager, Quality & Compliance, it is the responsibility of the Coordinator, Quality & Compliance, to assist with the maintenance of the Quality System documentation meeting Health Canada requirements as an importer and distributor of pharmaceutical products. 2.2 As delegated by the Project Manager, Scientific Affairs, it is the responsibility of the Coordinator, Scientific Affairs, to provide administrative support including submission compilation and filing of regulatory documentation in order to ensure compliance with applicable regulations and post-marketing requirements including pharmacovigilance monitoring and reporting. 3. General 3.3 Sunovion Pharmaceuticals Canada Inc. is focused on the commercialization of prescription products in Canada. The Quality System will be specifically designed to detect, correct and prevent GMP compliance issues under this operating model. 4. Policies/Standards 4.1 The Coordinator, Quality and Compliance, shall a) Assist in maintaining accuracy and completeness of the Quality & Compliance documentation system. b) Assist in maintaining processes for procurement, tracking, review and control of key documentation within Quality & Compliance. c) Track batch records and other documentation. d) Co-ordinate the review and revision of Standards Operating Procedures, Forms and Lists. e) Update controlled documentation in Compliance files. f) Track and maintain databases for complaints, changes controls, and deviations. g) Co-ordinate APQR documentation. h) Maintain the temperature monitor database. i) Maintain an orderly and well-organized filing area. j) Co-ordinate the receipt of receiving, sampling and inspection reports from the third-party logistics provider. k) Liaise with the third-party logistics provider for requesting the retention sample log on a quarterly basis, requesting and reviewing warehouse pest control and warehouse temperature reports, processing of Warehouse Damage Forms. l) Coordinate the retention of documentation offsite. m) Assist in the tracking of audit responses. n) Assist in the coordination of SOP training. o) Maintain return reports. p) Assist in the Annual Review of Files, and Documentation Archiving and Maintenance. q) Perform other related duties as required. 4.2 The Coordinator, Scientific Affairs, shall a) Process adverse drug reactions (receive, log, document assessments, submit, file) in accordance with internal SOPs and regulatory requirements and perform monthly reconciliation of ADR reports. b) Assist in the preparation of regulatory submission. c) Assist in the compilation of documents for level changes to maintain marketing authorization. d) Assist in the preparation of internal change controls. e) Maintain filing system for submissions and regulatory files, including Product Monographs, CPIDs and submission correspondence. f) Any other required activities to support daily operations within the Scientific Affairs department. Qualifications/ Requirements • Canadian university science degree or equivalent. • Previous experience in pharmaceutical quality and compliance environment, especially related to GMP requirements for importation and distribution is preferred. • Experience in a regulatory environment is an asset. • Strong organizational skills with attention to detail and accuracy. • Ability to work proficiently within Microsoft Office (Word, Excel, PowerPoint, Outlook) and Adobe. • Strong written and verbal communication skills. • Highly motivated and hard working. • Flexible, ability to adapt to changing priorities. please send all resumes to the following general mailbox: sunovionca@sunovion
Posted on: Wed, 30 Jul 2014 13:31:13 +0000
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