Labelling and Change Management Associate

3 weeks ago

Toronto, Canada Calea Ltd. 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.

Fresenius Kabi Canada is seeking a **Labelling and Change Management Associate** to join our growing **Quality Operations** team

**The Impact You Will Make**:
The Labelling and Change Management Associate (the Associate) manages the process for the creation of new or revised component labeling to ensure compliance with applicable Health Canada regulations and requirements. The Associate supports fabricator’s operations by ensuring approved labeling components are submitted to the fabricator’s printer on a timely basis. The Associate also supports the fabricator’s production by ensuring the document change request to modify the bill of material, master batch records are approved and implemented to support production schedule. This position is responsible for procuring supplies for the creation of marketing mock samples for contract tenders and for providing approved artwork for regulatory submissions.

This position also is responsible for managing change in fabricator processes, pharmacopeia, raw material and finished product to ensure the Company is GMP compliant with the market authorization. This position creates a dossier for each product family/site to ensure the released product meets the current market authorization, manages the change control process including the assessment of change, documenting the change(s) in the dossier. The changes can originate from the fabricator, Health Canada or pharmacopeia.

The Associate also communicates with the fabricator regarding changes to testing (finished product, raw material or stability) and specifications (raw material specification, finished product) and ensures the site takes the necessary actions to implement the Regulatory Affairs (RA)-directed change to the market authorization.

The Associate may also support analytical method transfer activities, liaising between the originating and contract laboratories and vendor management of contract laboratory facilities. This position also assists with providing support data for ECCnet registration.

**What You’ll Bring**
- _ Knowledge & Experience._ You have a Bachelor of Science degree in a life science (chemistry and/or microbiology preferred), some laboratory experience, prior experience in the healthcare or pharmaceutical industry.
- _ Communication & Presentation._ You have excellent communication & customer service skills and the ability to collaborate with all levels both inside and outside the organization. You also possess superb organizational and problem-solving skills with a focus on continuous improvement.
- _ Attitude & Passion_. You are self-motivated and able to work with mínimal supervision. You have strong attention to detail with the ability to multitask and handle fluctuating workloads. You maintain a high level of accuracy are results oriented and have the ability to prioritize efficiently.
- _ Technical experience_. You poseess knowledge of GMP, strong computer skills in Microsoft® Office and working experience in SAP is an asset.

***What We’ll Bring**
- _ 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.
- _ Impact_. You will be an integral part of the projects and initiatives that will contribute to the strategic planning and growth of the organization.
- 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._

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