Compliance Associate

As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 41,000 employees and presence in over 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies. WHAT WE OFFER!Benefits At Fresenius Kabi Canada we foster a collaborative environment where employees are encouraged to share ideas and contribute to meaningful work. We offer unique learning opportunities to grow and build your career. In addition, we value each and every contributor and offer various benefits and rewards (as applicable) including:

• Company paid health and dental benefits that start on your first day of employment
• Generous vacation plan
• Paid float days and paid sick days
• Employee assistance program
• Casual office dress code
• Employee recognition program
• Perkopolis & Goodlife Discounts
• Professional growth and development opportunities

We are currently seeking a full-time temporary (20 months) Quality Compliance Associate to join our team!Hybrid role, on-site requirement 3 days/weekLocation - 165 Galaxy Blvd., Toronto ON (Pearson Airport Area)The pay range for this role is:$75,000.00- $80,000.00.Placement within the range will be determined based on relevant skills, experience, qualifications, and internal equity. The final offer will reflect the successful candidate's background and demonstrated capabilities.This position is an existing vacancy within the organization.Main Responsibilities

• Manages information received from fabricators and relevant subcontractors to ensure that it is compliant with Good Manufacturing Practices (GMP) and as per market authorization.
• Requests, reviews and approves on an annual basis quality document such as validation reports, stability reports, APQRs, YBQRs, critical process assessments, deviations, complaints for each product.
• Writes annual product quality reports and updates the APQRs/YBQRs spreadsheet (tracking log) and follows up on recommendations.
• Writes, reviews, follows up with the fabricator and/or third-party contract testing lab for temperature excursion and thermal cycling protocols as appropriate.
• Communicates with fabricators for on-going commitment batches or as a result of regulatory action. Ensures that all the appropriate stability studies are carried out appropriately and in a timely manner.

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. Capable of handling several projects simultaneously.

MORE ABOUT US! As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale. In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is the global leader in supplying blood collection bags and devices, supporting blood banks and healthcare facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care. Fresenius Kabi takes a holistic approach to healthcare and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of almost 450 million patients annually. Inclusion and Equal Opportunity Employment At Fresenius Kabi Canada, we embrace diversity and inclusion for innovation and growth. We are committed to building inclusive teams and an equitable workplace for our employees to bring their true selves to work. We are taking actions to tackle issues of inequity and systemic bias to support our diverse talent, clients and communities. We are an equal opportunity employer. In accordance with the Accessibility for Ontarians with Disabilities Act, 2005 and the Ontario Human Rights Code, we are committed to providing accommodations and will work with candidates to meet their needs and provide an accessible candidate experience. If you are a person with a disability and require assistance during the application process, please let us know ( hrcanada@fresenius-kabi.com ). We welcome members of all backgrounds, experiences and perspectives to apply. Artificial Intelligence (AI) Use In Recruitment Fresenius Kabi uses AI-supported tools to help compare applicant résumés with job requirements and identify potential matches. These tools do not make hiring decisions. All candidate reviews, selections, and decisions are made by our recruitment team.