Quality Assurance Supervisor
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2Job Description
Quality Assurance Supervisor
Under the direction of the Director of Radiopharmaceutical Development and Manufacturing Quality
Manager, the Quality Assurance (QA) Supervisor ensures that quality standards and current procedures
meet or exceed Canadian and international regulations for Good Manufacturing Practices as well as the
standards set by Contract Manufacturing clients. Where necessary, works with other CPDC departments
to establish GxPs within the quality system.
The responsibilities listed can be delegated to team members at the discretion of the Quality Assurance
Supervisor.
Accomplishes Quality Assurance human resource objectives by recruiting, selecting, orienting,
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training, assigning, scheduling, coaching, counseling, and disciplining employees; communicating
job expectations; planning, monitoring, appraising, and reviewing job contributions; supporting
career development activities; enforcing policies and procedures. Human Resources issues are raised
to the Director in a timely manner to avoid inefficiencies within the group
Achieves Quality Assurance operational objectives by monitoring and assigning day-to-day activities,
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identifying and addressing gaps and problems; completing audits; implementing change and
providing regular feedback to the Director and stakeholders regarding system performance and issues
Performs the project management function for the group including resource planning, objective
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setting, communication of issues and reporting project progress to stakeholders
Serves as the Quality Assurance liaison with external clients for projects in all stages of clinical
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development, as well as for products having marketing authorization
Perform gap analysis through regular audits of Quality Systems and proposes plans to the Director
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and stakeholders to close gaps with the aim to continually improving the performance of Quality
System to meet recognized industry standards for radiopharmaceuticals
Work with Product Development and Production personnel to analyze and trend product
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performance through completion of Annual Product Quality Reports (Health Canada), Annual
Product Reports (FDA) and Quality Reports (Contract Manufacturing)
Host regulatory and client audits, and assumes responsibility for ensuring that stakeholders are
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included in proposals for corrective actions and that proposed corrective actions are completed in a
timely manner
Work closely with the departmental managers to ensure staff are working in compliance with internal
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policies and procedures, external client expectations and GxPs
Update job knowledge by studying trends in and developments in quality management; participating
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in educational opportunities; reading professional publications; maintaining personal networks;
participating in professional organizations
Meet weekly with the Director to track and set team priorities, and address issues and problems
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Oversee the day to day running of the group, monitoring and assigning tasks to meet the needs of
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QA, RA, Clinical, PD and manufacturing
Runs weekly team meetings and prepare minutes for distribution to stakeholders
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Complete all other duties as required to support the mission of the centre
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Parent category: Business