Quality Associate, Licensing

**_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** **Quality Associate - Licensing** **to join our growing Quality team

**The Impact You Will Make**:
The Quality Associate - Licensing is responsible for managing the Drug Establishment License (DEL) Foreign Site Annex and the Medical Device License (MDEL). This position is also responsible for compliance activities such as Regulatory Surveillance Collecting documents for the maintenance of the Narcotics License, Gap assessment of Health Canada Guidance documents, support for Quality team’s gQM assessments as well as back up for Quality Assurance Agreements (QAA) documentation and review process.

This position is the key liaison officer for all third-party site GMP related matters with the Canadian government, manufacturing sites and head office.

The Quality Associate - Licensing has direct impact on continuing quality compliance of Canadian operations. This position has indirect impact on company sales/profit growth by ensuring DEL Foreign Site Annex, MDEL and Narcotics licenses are in compliance with the regulations.
- Ensures DEL Foreign Site Annex is up to date
- Completes the annual DEL submission and fee calculation accurately
- Files DEL Amendments to add new foreign sites as necessary
- Completes the annual MDEL submission and fee calculation Completes the annual Narcotics submission and fee calculation
- Regulatory surveillance
- Collects information for Narcotics license
- Performs gap assessment of the Health Canada guidance documents
- Obtains and evaluates inspection reports for foreign sites
- Creates and maintains a database of foreign sites and associated GMP supporting information
- Writes and reviews protocols and final reports
- Writes, reviews, updates and trains on SOPs as required
- Assists with internal and external audits as needed
- Performs backup functions for Auditor in the QAA process
- Performs QA gQM assessment support
- Utilizes the Company’s documentation system to ensure GMP and ISO compliance
- Performs any other duties as assigned
**What You’ll Bring**
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Knowledge & Experience._ You possess an undergraduate degree in microbiology or another Life Science. You have 3+ years of pharmaceutical experience, which has given you in-depth knowledge of the manufacturing process, an understanding of technical reports, USP, GMP and GLP, and testing in chemistry and microbiology. Experience with manufacturing of sterile injectables, ISO and SAP is an asset. You have detailed knowledge of Canadian GMP.
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Technical experience_. You are proficient in Microsoft® Office, PowerPoint and Excel, and SAP. Your critical thinking and decision-making skills are above average, and you demonstrate excellent analytical skills and a high level of accuracy. You can effectively analyze data, possess strong investigative skills, and have strong interpretation and manipulation skills.
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Communication & Presentation. _You are a skilled leader and able to effectively communicate both written and verbally in collaboration with all level both inside and outside the organization.
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Attitude & Passion_. You are self-motivated and able to work productively with mínimal supervision. You have proven your ability to adhere to standards and procedures and maintain continuous confidentiality.
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Exceptional organizational and time management skills_. You maintain strong attention to detail with the ability to multitask and handle fluctuating workloads simultaneously. Your organizational and problem-solving skills are strong while identifying areas for continuous improvement. You have excellent project management and follow up skills and are deadline oriented with a strong ability to prioritize tasks.
**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