Senior Quality Assurance Associate

Job content

The Centre for Probe Development and Commercialization (CPDC)is a global leader of next-generation radiopharmaceuticals. At CPDC we are working with our partners to discover, develop and distribute the next generation of imaging agents and targeted radiotherapeutics for the detection and treatment of human diseases such as cancer. Our Centre has the full range of scientific, technical, regulatory and business expertise combined with specialized infrastructure required to translate radiopharmaceuticals from clinics to the commercial marketplace. Radiopharmaceuticals are perishable products that require just-in-time manufacturing.
CPDC’s success in the radiopharmaceutical industry results in the ability of our talented staff to develop reproducible processes that yield high quality products while adhering to international regulations governing nuclear safety, transportation of goods, and pharmaceutical manufacturing. Our staff takes pride in the impact we make every day in the lives of patients across the globe.

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About the Role: *
Reporting to the Manager of Quality Assurance Systems, the Senior Associate of Quality Assurance Systems leads processes and initiatives to ensure CPDC remains in compliance of its systems and Good Manufacturing Practices (GMP). These activities encompass the production for both clinical and commercial products, from the introduction of new programs to the routine manufacturing phase at CPDC facilities. This position will act as an interface between quality, radiopharmaceutical development, regulatory and production teams to ensure that all regulated activities are conducted in compliance with relevant regulations and internal procedures.
include (but are not limited to):

• Through on-going monitoring and review, ensures CPDC’s quality systems remain in compliance
• Works collaboratively with stakeholders to ensure CPDC systems are kept current with regulatory requirements, industry standards and CPDC processes
• Leads and drives continuous improvement initiatives that strengthen CPDC’s Quality Management System (QMS)
• Effectively drives the management and oversight of quality issues and recommends corrective/preventive actions to make decisions using problem-solving skills
• Reviews, assesses, and approves change control records and CAPAs (files and extensions) while ensuring proper risk-based impact assessment and evaluation of the associated deliverables
• Reviews, assesses, and approves non-conformances (files and extensions) while ensuring proper investigation, root cause analysis, risk-based impact assessment and the establishment of effective corrective/preventive actions
• Leads the self-Inspection program, including maintaining the annual schedule, conducting audits, and preparing reports
• Participates in on-site audits by regulatory authorities and CPDC clients, including preparation and follow-up activities
• Develops and provides training on department-specific procedures/systems and quality-related topics
• Co-ordinates the supplier qualification program and participate in vendor audits
• Prepares and maintains Quality Technical Agreements for vendors and service providers
• Prepares quality performance metrics and provides monthly/annual reports to Quality Assurance Management as required
• Support document management system activities
• Acts as a designate for the Manager of Quality Assurance Systems (when/where required)
• All other duties as assigned

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Requirements: *

• BSc or equivalent in Pharmacy, Engineering, Chemistry, Microbiology or a related field
• 5 to 7 years of relevant experience in the pharmaceutical, radiopharmaceutical or biopharmaceutical industry
• Working knowledge and hands-on experience with audits, qualification, validation, vendor management, and quality management systems
• Strong understanding of Health Canada and FDA GMP regulations, with specific knowledge of regulations as they pertain to sterile products
• Adaptable with a desire for working in a fast-paced, growth oriented environment
• Ability to work with a sense of urgency, prioritize work, meet objective/deadlines with strong organizational skills
• Strong project management skills with the ability to work independently and within a team
• Able to drive improvement projects and deliver high-quality work even under pressure
• Ability to handle multiple tasks and competing priorities concurrently and in a timely fashion
• Ability to solve problem with evidence of good judgment and decision making skill
• Flexibility in work schedule to support a 24/7 production environment
• Strong client-facing and teamwork skills

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CPDC offers: *

• Competitive compensation
• Medical and dental benefits, sick days & more
• Opportunity for long-term growth
• Professional & collaborative environment with experienced individuals in the field
• Join a passionate team making a difference in patients’ lives and Canadian

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If you require accommodation for your application or interview, please contact Human Resources directly at 905.525.9140 ext. 21112 or by email at _careers@imagingprobes.ca
We thank all those who apply but only candidates selected for interviews will be contacted.

Job Type: Full-time