Quality Auditor (Full-Time)

at  Fresenius Kabi Canada

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 full-time Quality Auditor to join our team!

POSITION SUMMARY:

The Quality Auditor is responsible for performing third-party GMP and Vigilance inspections on fabricators, testing labs, and warehouses and internal departmental inspections for Fresenius Kabi Canada Ltd. (the Company). This position is responsible for the administration and management of quality agreements with fabricators, warehousing, wholesalers and laboratory services. This position requires the incumbent to travel up to 35% of the time. This position is the key liaison officer for all third-party site GMP related matters with the Canadian government, manufacturing sites, and head office.

QUALIFICATIONS

• Minimum of Bachelor degree in Microbiology/Life Science required with a minimum of three years of experience in pharmaceutical quality assurance
• Prior experience in the healthcare or pharmaceutical industry is required
• Qualified Pharmaceutical GMP and GLP auditing experience required
• ASQ certification is an asset
• ISO 9001 and ISO 13485 standards knowledge is an asset
• 35% international travel required. Must possess valid Canadian passport.
• Detailed knowledge of Canadian GMP required
• Knowledge of European Union and United States FDA cGMP is an asset
• Knowledge and working relationship with Health Canada personnel is desirable
• Medical device and sterile manufacturing knowledge is an asset

SKILLS

• Strong understanding of Canadian, US and EU GMP Regulations
• Excellent communication skills (written and verbal)
• Excellent customer service skills and the ability to collaborate with all levels both inside and outside the organization
• Strong computer skills in Microsoft® Office 365
• Self-motivated and able to work with minimal supervision
• Strong attention to detail with the ability to multitask and handle fluctuating workloads
• Excellent organizational and problem-solving skills
• Excellent continuous improvement skills
• Proven ability to adhere to standards and procedures and maintain confidentiality
• Proficient in documenting and writing reports
• Understanding of TrackWise/KabiTrack/CAPA systems and equipment validations is an asset
  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 meet the accessibility requirements prescribed by the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation at any time please contact us. Fresenius Kabi Canada is an Equal Opportunity Employer.

Please refer the Job description for details