Job Summary :
The QA Specialist will assume responsibility for the ongoing development and maintenance of the Quality Management System within the country, providing internal guidance, support, risk assessment and training to KN business and functional units.
Please note the distribution centre is located in Markham.
Roles and Responsibilities :
Facilitate implementation and compliance activities in alignment with cGMP's, corporate policies and procedures, client SOP's and applicable regulations across all business and functional units in the country
Ensure that existing and future QA requirements are cascaded to and implemented by country business units and operations
Actively participate, support, and when required lead audits from existing and prospective clients, as well as regulatory bodies
Perform internal self-inspections
Conduct supplier / vendor audits
Facilitate development of training strategies
Support the development of pro-active strategies as preventive measures against potential future issues with systems or processes
Identify and investigate incidents from a quality perspective
Complete non conformity and planned deviation reports and oversee the execution of CAPA commitments
Support national QA management as required
Ability to perform as RPIC and QPIC. The RPIC will assume full responsibility for all transactions involving precursors.
The QPIC will assume full responsibility for all transactions involving controlled and targeted substances and controlled and targeted substances.
Other duties as assigned
1-8+ years of professional experience in pharmaceutical Quality Assurance
Advanced knowledge and understanding of GMP's, GDP's, licensing, Federal and Provincial regulations and guidelines
Knowledge of Quality Management systems and standards
Post-secondary diploma / degree; desired Bachelor in Sciences (e.g. Pharmacy, Chemistry, Biology)
Diploma / Degree / Certificate in Quality Assurance is preferred
Able to converse fluently with various stakeholders, including : operators, management, regulators and customers.
Strong critical thinking skills; comfortable with the management and application of complex subjects
Able to translate concepts into practical application.
We offer competitive compensation, a comprehensive benefits package, employee discounts, tuition reimbursement, excellent training programs and a highly dynamic global work environment.
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.
At this time, we are considering only local candidates who are able to work without employer sponsorship. No agencies or phone calls, please.
Only those candidates whose experience best meets our requirements will be contacted.
Kuehne + Nagel Ltd. is an Equal Opportunity Employer.