Centre for Probe Development and Commercialization
  • Toronto, 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. CPDC offers career growth and development in a highly entrepreneurial environment.  CPDC offers medical and dental benefits, sick days and more.

CPDC is one of the very few R&D centres that has the full range of scientific, technical, regulatory and business expertise required to translate radiopharmaceuticals to local and international clinical trials and the marketplace.

This position is located in Toronto, Ontario.

 Position Profile:

Reporting to the Quality Assurance Manager, you will;

  • Be responsible for QA activities associated with validation and supply of CPDC products; these include review of non-conformance reporting and investigations, as well as follow up with CAPAs and change control activities;
  • Participate in quality audits (internal and external) as required
  • Participate in Batch Record Review to release marketed and clinical products for use, as well as retrospective Batch Record Close-out
  • Review standard operating procedures (SOPs) and other controlled documents for compliance with regulations and propose changes to Quality Assurance Manager for review and approval
  • Review and approve specifications for incoming raw materials and finished products.
  • Review reports for compliance with protocols, quality system and regulatory requirements
  • Assist in drafting and reviewing Annual Product Quality Reviews
  • Develop and maintain an in-depth knowledge of key regulations and guidance documents pertinent to Product Development and Quality
  • Participate in building the CPDC Quality System according to Health Canada and FDA regulations, ICH Q10 and ISO guidance

 

Qualifications and Requirements:

  • A post-secondary education in the life sciences with experience in a GMP or equivalent regulated environment
  • Certificate in Quality Assurance is considered an asset
  • Strong understanding of Health Canada, FDA and EU GMP regulations
  • Proficiency in the English language; both written and oral
  • Ability to work independently and possess excellent organizational skills
  • A minimum 5 years' experience working in a GMP or equivalent regulated environment, with at least 2 years' experience in a Quality Assurance Role

 

Please note this role requires flexibility based on project demands and deadlines

 

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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