Manager – Quality Assurance

• Provide QA and technical support globally to external suppliers in order to ensure that commercial products are manufactured in compliance of GMP. Oversee quality-related licences and functions for the local operation including controlled drug activities;
• Support and assist in coordinating Global Affiliates activities in compliance with local regulations and the company Global Quality Manual;

Responsibilities:
• Collaborate with Global QA teams to support all QA activities related to products manufactured at third party suppliers. Provide support for change control activities, global SOP review, complaint investigations, recalls and QA audit. Support the timely completion of annual Product Quality Reviews (25%);
• Support local affiliate product launches and marketed products, local regulatory inspection, technology transfer, Technical Agreements and other issues related to GMP. Oversee quality-related licences and functions for the local operation, supervises activities of administrative staff and assume role for handling of Controlled Substances permits (20%);
• Ensure that GMP aspects are covered and potential risks identified, investigated and reported to Senior Management 10%;
• Develop close relationships with other functions in GSC e.g. Global Pharmaceutical Technology, Materials Management and Supplier Relationship Management (10%);
• Maintain good working relationships with external suppliers on a global basis (10%);
• Review of Master batch documents and executed batch documents received from suppliers for local product release and to liaise with suppliers regarding any queries. (10%);
• Provide technical support to Global Affiliates LOC training on Global SOPs. Ensure harmonization of processes and procedures between QA and affiliates on a global basis (10%);
• Review and approve artwork for printed packaging materials.(5%). 

. University degree or equivalent qualification in Life Science subject • Practical experience of at least 7 years in the Pharmaceutical Industry, a majority of which has been gained in a QA/QC environment, and including manufacturing • Experience of working with suppliers • Excellent knowledge of Health Canada GMP regulations, plus good awareness of other GMP requirements eg ICH, FDA • Bilingual (French and English) Key Skills and Competencies • Ability to multi-task in environment with changing priorities • Good interpersonal and communication skills • Able to work with many organizations / cultures / quality systems

Complexity and Problem Solving • Solves problems whilst maintaining Quality Standards and considering the company Policy • Understands total potential impact and contributes significantly to the solution of simple or complex issues arising • Expected to work with a number of suppliers / products • Uses experience to facilitate troubleshooting, and to tackle non-routine work and projects independently • Offers constructive comments and proposes improvements and rationalizations to systems, policies and procedures • Uses own judgement to assess what to refer upwards and what to deal independently

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