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.

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 Hamilton, Ontario.

Responsibilities and job tasks include (but are not limited to):

  • Through on-going monitoring and review, ensures that the quality systems are in compliance with regulatory requirements and meet the needs of the CPDC and its clients
  • Works collaboratively with stakeholders to ensure the systems are kept current and are effective
  • Maintains performance metrics and provides regular feedback to the QA Director and stakeholders regarding system performance and issues
  • Performs gap analysis through regular audits of Quality Systems and proposes plans to the QA Director  and stakeholders to close gaps with the aim to continually improve the performance of the Quality System to meet recognized industry standards for radiopharmaceuticals
  • Work with technical teams to trend and analyze product performance through completion of Annual Product Quality Reports (Health Canada), Annual Product Reports (FDA) and Quality Reports (Contract Manufacturing) where applicable
  • Participates in on-site audits by regulatory authorities and clients, including preparation and follow-up activities
  • Acts as a designate for the Quality Assurance Director and the Quality Operations Supervisor (when / where required)
  • Oversees control of document management system according to internal procedures
  • Responsible for efficient and compliant organization of document management system, ensuring that stakeholder needs are met
  • Oversees on-site and off-site storage of documents according to needs of CPDC and clients
  • Microbiology and Environmental Monitoring (EM):
  • Oversees the compliance review of Microbiology and EM reports
  • Meet on a regular basis with the QA Director to provide updates on ongoing activities, track and set priorities, and address issues and problems
  • Complete all other duties as required to support the mission of the Centre

Education/Qualifications:

  • Sc. with at least 5 years' experience in a GMP or equivalent regulated environment
  • Proficiency in the English language both written and oral, with excellent communication skill
  • Ability to work independently and possess excellent organizational skills
  • Demonstrated ability to successfully prioritize, manage time well, multitask and troubleshoot
  • Knowledgeable in use of spreadsheets, database, and word processing software
  • Pharmaceutical industry experience or experience within a highly regulated technical environment (e.g. GMP)
  • Strong computer skills with the ability to rapidly input data and retrieve records and information
  • Demonstrated ability to think strategically and identify a vision along with the plans which need to be implemented to meet the end goal
  • Ability to develop and maintain relationships with internal and external business partners
  • Strong communication skills with various levels of the organization
  • Proven ability to assess and make risk-based decisions while keeping stakeholders appraise
  • Experienced in assessing a situation, identifying issues and developing solutions that result in efficiencies or process improvements
  • Demonstrated leadership capability (i.e. takes initiative to lead self and others, to lead by example and follow through to completion often with minimal direction)
  • Ability to work with a sense of urgency, prioritize work, meet objective / deadlines with strong organizational capability
  • Successfully demonstrated ability to coach others with a strong self-awareness (both strengths and opportunities) and ability to self-develop
  • Ability to adapt to change and work flexibly to overcome boundaries
  • Strong project management skills with the ability to work independently and within a team
  • Ability to adjust work schedule based on business requirements

Other Requirements:

  • Flexibility in work schedule to support a 24/7 production environment (e.g. to take short calls to support production)
  • Use leadership skills to solve and address problems with employees

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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