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Supply Chain Compliance Specialist
2 weeks ago
**_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** **Supply Chain Compliance Specialist** to join our growing team**
This is a hybrid role, with presence required in our headquarters at 165 Galaxy Blvd. 2 to 3 times per month.
**The Impact You Will Make**:
The Supply Chain Compliance Specialist is an integral part of Fresenius Kabi’s Supply Chain team and ensures that all compliance activities are completed. The Compliance Specialist ensures policies and procedures are followed according to regulations and standard operating procedures (SOP). This role works cross-functionally to ensure compliance of the supply chain group with regulations and ISO standards including, but not limited to GUI-0001, GUI-0069, Narcotic/Controlled Drug Regulations and ISO 9001 and 13485. In addition, this position will assist management and cross functional teams in ensuring all third party vendors comply to Fresenius Kabi requirements and stated regulations.
- Works with the team to complete incident investigations, root cause analysis, and implement corrective actions (Internal and Supplier Corrective Actions) as they pertain to supply chain actions and activities
- Support completion of Transportation Lane Qualifications (GUI 0069 requirements) for defined transportation lanes, both existing and new per product launch plans.
- Serves as the supply chain compliance representative on gap assessments (against Global SOP’s, Health Canada Guidance Documents, etc.) and other initiatives
- Audits processes and documentation to verify accuracy and compliance at critical process points
- Initiates and/or reviews deviation investigations to help define necessary corrective actions to ensure complete, thorough, accurate and timely evaluation of non-conformances and prevention of reoccurrence
- Responsible for development and maintenance compliance KPI’s within the department
- Represents SCM (Supply Chain Management) department at meetings related to compliance topics incident investigations, root cause analysis & corrective actions.
- Updates, reviews procedures and applicable documents as assigned.
- Assist with regulatory gap assessment and change controls on behalf of SCM.
- Performs internal self-assessment to ensure procedural compliance within the department
**What You’ll Bring**
- _ Knowledge & Experience._ A Bachelor of Science degree in Life Science is preferred. 3-5 years of experience in a cGMP environment (Health Canada GUI-001, GUI-0069) is preferred. Prior pharmaceutical industry experience is required.
- _ Technical experience_. You have working knowledge of various QMS systems and supply chain processes, and working knowledge of SAP and Microsoft Office Suite.
- _ Communication & Presentation. _You are able to effectively communicate both written and verbally in collaboration with all level both inside and outside the organization.
- _ 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.
- _ 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**
- _Exposure. _The hands-on experience and exposure to a global organization, combined with the mentorship of a dynamic and knowledgeable Supply Chain team.
- _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 disco
