We are looking for a Senior Quality Assurance Specialist for our Contract Logistics division/office based in Brampton.

Your Role

The Senior Quality Assurance Specialist, reporting to the QA Manager, will assume responsibility for the ongoing support and maintenance of the Quality Management System at the local level within the assigned business unit(s), where Distribution and Wholesaling is applicable. You will implement branch Quality functions employing knowledge including: cGMP\'s, corporate guidelines, company work instructions, client SOP\'s, and all the applicable Health Canada regulations associated with the responsibilities performed at the assigned business unit(s) (e.g. narcotic control, controlled drugs and substances, precursors, etc.). #LI-Onsite

Your Responsibilities

• Facilitate the implementation and compliance activities following cGMP\'s, corporate procedures, client SOP\'s and applicable regulations across all departments
• Ensure that GxP requirements are bein met on site
• Assist the flow of Operations including Inbound, Returns, Destruction, etc. where Quality support may be required
• Release and quarantine product in accordance to client or Kuehne+Nagel instructions and regulatory requirements
• Facilitate product complaint/inquiry requests, investigations and trending as per client or Kuehne+Nagel requirements
• Monitor temperature conditions of the facilities if applicable review inbound product temperature conditions;
• Oversee Preventative Maintenance activities and maintain list of qualified vendors
• Train and oversee Level I and II staff as assigned
• Support Operations in the maintenance of the site training programme and applicable documentation
• Develop change controls, WI\xe2\x80\x99s, and SOP\xe2\x80\x99s using working knowledge of GMP\xe2\x80\x99s and industry standards
• Support operations or completes, executes, and oversee non conformity, CAPA, and planned deviation reports
• Oversee the daily operational transactions of CDS (Controlled Drugs and Substances) /PCR (Precursor Control Regulations) products and fulfill regulatory reporting obligations per OCS (Office of Controlled Substances) regulations
• Assist QA Manager with new client / product onboarding / setup preparation
• Oversee daily activities of QA Specialists, monitoring of work quality and productivity as assigned by the QA Manager
• Other tasks as may be assigned relative to the assigned site and additional sites in the Pharma/Healthcare Canadian region

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

• 5+ years industry experience in Medical Device/Pharmaceutical industry in QA. RA experienced may be considered
• 2+ years industry experience in Medical Device/Pharmaceutical distribution
• Meet Health Canada\'s requirements to perform RPIC and QPIC responsibilities
• Knowledge of Quality Management systems and standards (i.e: GMP, ISO 13485, ISO 9001)
• Knowledge of GMP\'s, GDP\'s, licensing, Federal and Provincial regulations
• Bachelor in Sciences (e.g. Pharmacy, Chemistry, Biology or a related discipline) is required
• Canadian equivalency required if the degree was awarded outside Canada or the US

Good Reasons to Join

We offer competitive compensation, a comprehensive benefits package, employee discounts, tuition reimbursement, excellent training programs and a highly dynamic global work environment. Kuehne+Nagel\xe2\x80\x99s general working model is a hybrid model depending on the job location, function, etc. The working schedule specific details will be discussed in your job interview. Kuehne+Nagel reserves the right to change or adjust the working model policy.
About 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\xe2\x80\x99s 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.aquisition@kuehne-nagel.com




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