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 full-time Project Lead, QA Labelling to join our Quality team.
BASIC FUNCTION
The Project Leader, QA Labelling reports to the Senior Manager, RA Labelling in the Scientific affairs department.
The Project Leader, QA Labelling is responsible for the daily operation of the QA Labelling functional area to manage change activities for all labeling components associated with labeling product life cycle management, product launches and regulatory submissions for Fresenius Kabi Canada. This position manages coordination efforts of all local business functions (principally Regulatory Affairs Labelling, Supply Chain Management, Marketing and Vigilance) involved in the creation, management, and control of labeling components.
JOB RESPONSIBILITIES
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Provides labeling projects oversight to employees in Labelling team in accordance with the company’s policies and procedures to meet the company’s expectations for productivity and quality
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Manages planning of the various steps in the change process to implement the new product labeling or new label component version ensuring business needs, including product launches and minimal disruption to product supply, are met
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Manages and oversees the change control process (author, route to internal stakeholders, review the assessments and approval) for labelling change activities
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Manages external service providers and stakeholders responsible for the various change steps principally the outsourced artwork service provider and contract manufacturing organizations
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Is responsible for reporting on progress and specific issues pertaining to quality labelling activities
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Under direction of the management, develops the strategies and cascades the appropriate detailed instructions to the associates
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Develops, implements and manages appropriate SOPs and systems to track and manage technical tasks
QUALIFICATIONS
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Minimum Bachelor of Science degree preferably in Chemistry, Pharmacy or Life Sciences
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Minimum five years pharmaceutical experience in quality assurance/control
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Prior experience in the pharmaceutical manufacturing for injectable products is preferred
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Strong Knowledge of good manufacturing practices (GMP), risk management and quality management principles
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Understanding and knowledge of Canadian labeling requirements is required.
SKILLS
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Excellent communication skills (written and verbal)
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Excellent customer service skills and the ability to collaborate with all levels both inside and outside the organization
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Self-motivated and able to work independently and monitor the associate’s projects.
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Strong computer skills in MS office and Adobe Acrobat
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Analytical skills to assess problems and present solutions are required
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Strong attention to detail with the ability to multitask and handle fluctuating workloads
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Excellent organizational and problem-solving skills
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Excellent continuous improvement skills
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Ability to work well under pressure in a team-based environment
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Proven ability to adhere to standards and procedures and maintain confidentiality
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Working experience in SAP is an asset
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Proven initiative
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.
