Centre for Probe Development and Commercialization
  • Hamilton, ON, CAN
  • Full Time

Company Profile:

The Centre for Probe Development and Commercialization (CPDC) is dedicated to fostering the discovery, development and distribution of next-generation radiopharmaceuticals that are used daily for the detection and treatment of human diseases such as cancer.

The supervisor is a focused and motivated individual with responsibility for GMP compliance of routine production for both investigational and commercial products at facilities run by CPDC.  In this capacity, the incumbent is responsible for managing a team of QA associates performing routine batch release, retrospective close-out and other associated activities.  The supervisor will work within a cross-functional matrix to ensure that CPDC meets the appropriate compliance standards, as it relates to GMP.

This position is based in Hamilton.

Specifically and under direction of the Director, Quality Assurance, responsibilities and job tasks include:  

  • Monitor and assign day-to-day activities of direct reports, responsible for Batch Record Review to release marketed and investigational products, as well as retrospective Batch Record Close-out
  • Responsible for scheduling, resource planning, objective setting, and communication of issues for direct reports, liaising with other groups as required
  • Works closely with MOPD and Regulatory to ensure timely and appropriate decision-making and reporting related to quality issues.
  • Reviews and approves non-conformance reports and laboratory investigations; follows up on CAPAs and change controls as required
  • Reviews and approves environmental monitoring data, excursions and trends
  • Reviews and approves Annual Stability data and reports
  • Works closely with the departmental managers to ensure staff are working in compliance with internal policies and procedures, external client expectations, and GMPs
  • Represent Quality Assurance on project teams to ensure efficient transition of manufacturing processes from validation to routine production as it relates to compliance
  • Reviews and approves controlled documents including SOPs, MBRs, STMs, CFs and SPECs for compliance with regulations. Identify areas for improvement and propose changes for review and approval
  • Support and release of raw materials for use in manufacturing and testing, as required
  • Maintains metrics for all routine production, provides data for reporting purposes and reviews and approves relevant reports
  • Participates in regulatory and client GMP inspections, as needed
  • Updates job knowledge by studying trends and developments in quality management; participates in educational opportunities, reading professional publications, maintaining personal networks, and participating in professional organizations
  • Accomplishes QA human resource objectives by training, assigning, scheduling, coaching,; communicating job expectations;, monitoring, appraising; supporting career development activities; and enforcing policies and procedures
  • Work with HR to develop an approach to address any problems with employees
  • Complete any other related duties that support the core activities and mission of the Centre, as required

Requirements:

  • Flexibility in work schedule to support a 24/7 production environment
  • Use leadership skills to solve and address problems with employees

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.

 

Centre for Probe Development and Commercialization
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