Job Description
Your Role
As Sr. Quality Assurance Specialist, you will support and maintain the Quality Management System at the local level within assigned business unit(s), where Distribution and/or Wholesaling is applicable. You will support Quality Assurance manager in overseeing multiple sites (Montreal & Edmonton). In addition, you will support National QA Business projects and completion of regulatory body licensing.Your Responsibilities
- Lead, facilitate and execute implementation and compliance activities as per cGMP's, corporate policies and procedures, client SOP's and applicable regulations across all business and functional units (Distribution and/or Wholesaling)
- Provide oversight, leadership and support for release and/or quarantine of product in accordance with client or Kuehne-Nagel instructions and regulatory requirements
- Inspection of finished products and product sampling for testing and retention purposes per client or Kuehne-Nagel requirements
- Management of product complaint/inquiry requests, investigations, and trending as per client or Kuehne-Nagel requirements
- Temperature monitoring of the facilities and if applicable review inbound product temperature conditions
- Preventative Maintenance activities and maintenance of the list of qualified vendors, site documentation control and records retention.
- Review, sign off, and oversee QA records such as certificates of destruction, calibration records, sanitation, pest control etc.
- Support the QA Manager/Supervisor with the preparation and presentation of Quality Key Performance Indicators to the leadership team and client as required
- Tracks relevant Quality System Metrics including deviations, change controls, CAPA, complaints and recalls, uses metrics to identify and pursue quality improvement initiatives.
- Supports National projects and initiatives.
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Actively participate, support, and lead audits from existing and prospective clients, and regulatory bodies.
Assist QA Manager/Supervisor with new client / product onboarding /setup preparation - Travelling is needed for this role (Quarterly)
If you require an accommodation for the recruitment /interview process (including alternate formats of materials, or accessible meeting rooms or other accommodation), please let us know and we will work with you to meet your needs.
Your Skills and Experiences
- Bachelor’s in sciences (e.g. Pharmacy, Chemistry, Biology or a related discipline) is required
- 5+ years of experience in similar role is needed
- 2+ years of Industry experience in Healthcare distribution is preferred
- Bilingual in French and English is needed
- Comfortable is travelling (Quarterly)
- Advanced experience/knowledge in Quality Management systems and standards (i.e. GMP, ISO 13485, 14001, 90001, 180001)
- Advanced knowledge and understanding of GMP's, GDP's, licensing, Federal and Provincial regulations and guidelines
- Leadership and managerial skills preferred
Good Reasons to Join
There has never been a better time to work in logistics. Bring your skills to an industry that offers stability and international career growth. We offer a great compensation and medical/dental benefits package, employee discounts, tuition reimbursement, excellent training programs, and a fun, and interesting global work environment. #LI-ONSITEAbout Kuehne+Nagel
With over 80.000 employees at some 1,300 locations in over 100 countries, the Kuehne+Nagel Group is one of the world’s leading logistics companies.
As an employer, Kuehne+Nagel stands for equal opportunity and we are committed to diversity in our teams with regard to people with disabilities. We believe that you can make a valuable contribution to Kuehne+Nagel and look forward to receiving your application.
CONTACT
Canada Talent Acquisition
USA.Talent.Acquisition@Kuehne-Nagel.com
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