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Compliance Associate

4 weeks ago

Toronto, Canada Calea Limited Full time

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 — 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.

We are currently seeking a temporary Compliance Associate to join our Quality team.

BASIC FUNCTION

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 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, 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 the company 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. 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 meeting the accessibility requirements prescribed by the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation at any time, please contact us.

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