The Senior 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.
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
• Other duties as assigned
• 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, Engineering or a related discipline)
• 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 and global work environment.
Reference Number: req28115