WHO WE ARE: 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 and the opportunity to work with managers who care about their professional development. We value integrity, encourage collaboration, celebrate passion, reward creativity, and demand excellence \xe2\x80\x94 because our customers deserve nothing less and our customers are at the heart of every one of our goals. As a part of Fresenius Kabi, you can enjoy an exciting career, a company culture based on a clear purpose and values, and the knowledge that your work makes a real difference. If you would like to learn more about us, we would love to hear from you. This is an exciting opportunity to join our Quality team as a full-time Compliance Associate! THE IMPACT YOU WILL MAKE: The Compliance Associate manages information received from fabricators and relevant subcontractors to ensure that it is compliant with Good Manufacturing Practices (GMP) and as per market authorization. This position manages the process of requesting, receiving, reviewing and approving various forms of technical data from all fabricators to ensure compliance to market authorization. The data includes the following reports: equipment 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 change. This position manages medical device compliance aspects as well. 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 the company internal stakeholders, the customer and the fabricators. This role will be responsible to support product launches and product lifecycle management for their assigned portfolio. WHAT YOU\xe2\x80\x99LL BRING: Knowledge & Education. You possess a Bachelor of Science degree. You may also have completed a diploma in Pharmaceutical Quality Assurance & Quality Control. Experience & Skills. You have a minimum of three years of experience handling QA compliance based activities, preferably in the quality department of a pharmaceutical organization. You are USP, GMP and GLP savvy. You have the proven ability to write technical reports. Attitude & Passion. You are self-motivated and able to work productively with minimal supervision. You have proven your ability to adhere to standards and procedures and maintain continuous confidentiality. You are passionate about process improvement and making suggestions to drive change. Technical Experience. You are proficient in Microsoft\xc2\xae Office, PowerPoint and Excel. Your critical thinking and decision-making skills are above average, and you demonstrate excellent analytical skills and high level of accuracy. WHAT WE\xe2\x80\x99LL BRING Exposure. The hands-on experience and exposure to a global organization, combined with the mentorship of a dynamic and knowledgeable Quality team. You will be an integral part of reviewing SOP\xe2\x80\x99s and processes to drive efficiency. Impact. Direct influence on patient care by ensuring the safety and quality of our products in the Canadian market. Positive Collaborative Environment. A welcoming, fun and energetic team environment that encourages open communication and collaboration. Our culture encourages our employees to hone current skills and build new capabilities, while discovering their genius.
The company is committed to meeting the accessibility needs of people with disabilities. Fresenius Kabi Canada & Calea Ltd. is dedicated to breaking down barriers to accessibility, preventing new barriers from arising and to meeting the accessibility requirements prescribed by the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation at any time, please contact us.