Compliance Associate

3 weeks ago

Toronto, Canada Fresenius Kabi Canada Full time

Join to apply for the Compliance Associate role at Fresenius Kabi Canada Caring for Life. Make a difference. Be the difference. If you are looking to work for a growing, global corporation that is focused on making meaningful improvements in the safety, affordability, and availability of the care medical professionals provide to their patients, then you should consider Fresenius Kabi. We are an employer that works to build great leaders, teams and businesses. We know our employees are key to everything we accomplish, so we give them the freedom and resources to reach their potential. We value integrity, encourage collaboration, celebrate passion, reward creativity, and demand excellence — because our customers deserve nothing less and our customers are at the heart of every one of our goals. We are currently seeking a temporary Compliance Associate to join our Quality team. The Compliance Associate manages information received from fabricators and relevant subcontractors to ensure compliance with Good Manufacturing Practices (GMP) and market authorization. The position manages the process of requesting, receiving, reviewing, and approving various forms of technical data from all fabricators to ensure compliance with market authorization, including equipment, processes and packaging qualification, validation, stability, annual product quality review (APQR), yearly biologic product review (YBPR), temperature excursion and thermal cycling study, critical process assessment, deviation, complaint, recall, regulatory audit, and manufacturing changes. The Compliance Associate also communicates with the fabricator on any corrections or changes to process equipment, methods, specifications that may affect the final product and regulatory approval of the market authorization, authors technical documents such as annual product quality reviews, validations and protocols and acts as a liaison between internal stakeholders, the customer and the fabricators. Qualifications Minimum Bachelor of Science degree Minimum 1 year relevant experience in handling QA compliance based activities In-depth knowledge of USP, GMP and GLP, testing technology in chemistry and/or microbiology Experience with manufacturing of sterile injectables, ISO and SAP system would be an asset Prior experience in the healthcare or pharmaceutical industry is preferred Must possess and demonstrate good judgement and decision-making skills Must be proficient in word processing, charting, and Excel spreadsheets Must be proficient in writing technical reports Must be highly organized and capable of handling several projects simultaneously The company is committed to meeting the accessibility needs of people with disabilities. Fresenius Kabi Canada is dedicated to breaking down barriers to accessibility, preventing new barriers from arising and to meet the accessibility requirements prescribed by the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation at any time, please contact us. #J-18808-Ljbffr

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