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Quality Control Supervsior

2 weeks ago

Hamilton, Canada Centre For Probe Development And Commercialization Full time

The Centre for Probe Development and Commercialization (CPDC) is a leading provider, on a global basis, of next-generation radiopharmaceuticals that are used daily for the detection and treatment of human diseases such as cancer.
Radiopharmaceuticals are perishable products that require just-in-time manufacturing on a daily or weekly basis to ensure supply demands are met without interruption. CPDC's success in the radiopharmaceutical industry results from the ability of our talented and committed staff to develop and manufacture high quality products, while adhering to international regulations governing nuclear safety, transportation of dangerous goods and pharmaceutical manufacturing.
**About the role**:
**Location: Toronto**
**Duties/Responsibilities include**:

- Provide leadership, technical guidance, supervision and hands-on support to ensure successful translation of diagnostic and therapeutic radiopharmaceuticals along the development pathway to commercial launch.
- Day-to-day coordination and schedule of activities of assigned analysts/technicians to ensure all required daily testing is completed for pre-clinical, clinical, and commercial materials.
- Work with clients and internal departments to create and manage detailed project plans such that client timeline and budgetary expectations are met.
- Oversee client projects and client communications, prepare presentations, attend client meetings and provide client technical support as needed.
- Monitor progress and ensure timely completion of investigations, non-conformances, CAPAs, and change controls.
- Ensure that team is able to plan, implement and complete assigned tasks in a timely fashion ensuring consistent high quality in accordance with GMP and CPDC SOPs
- Carry out analytical method development, transfer, troubleshooting, and validation.
- Perform quality control testing of incoming materials, drug substances, and drug products according to standard operating procedures
- Ensure that routine quality operations including installation/calibration/maintenance of equipment, reagent inventory, and facility housekeeping are properly maintained.
- Conduct peer review of laboratory records and ensure adherence of assigned staff to GMP regulations by reviewing records pertaining to all aspects of analytical and microbiological testing, routine operations, and equipment maintenance.
- Conduct investigations for testing failure and non-conformances, and implement corrective actions.
- Write, revise, create and review technical documents, including INVs, NCs, CAPAs, validation documents (protocols, reports), STMs, SOPs, specifications, change controls, etc. according to regulatory guidelines (ICH, USP, etc.) with input from SMEs, for review by management, QA and/or customers. Write test reports, data summaries, and statistical evaluations/trending.
- Maintain a working understanding of appropriate regulatory guidance, international pharmacopeias, ICH, established business processes and protocols, and applicable standard operating procedures.
- Responsible for understanding and working under the Health Canada GMP requirements for sterile pharmaceuticals and the Annex to the GMPs for Positron Emitting Radiopharmaceuticals (PERs).
- Manage training plans for assigned staff and ensure sufficient cross-training is in place to allow for completion of daily tasks. Identify and assist in conducting cross functional training to maintain and improve the growth of employee knowledge and the flexibility of staff to support process development and production.
- Conduct performance reviews and establish performance expectations and performance improvement plans.
- Continually work on broadening technical expertise of self and the team to support current products and develop future drugs within the company portfolio or through support of our CDMO functions.
- Maintain current industry knowledge in analytical quality topics, regulations, and publications.
- Accomplish human resource objectives by training, assigning, scheduling, coaching, communicating job expectations, monitoring performance, conducting performance reviews, supporting career development activities; and enforcing policies and procedures.
- Conducts self and all activities with the highest level of competency and reliability, follows company policies and procedures and shows support for the organization’s goals and values.
- Shows understanding for unique challenges of radiopharmaceutical industry with respect to shifts, hours, and overtime.
- Works collaboratively with team members to ensure that tasks are covered in the event of unexpected absences.
- Maintain an accurate training record.
- Adhere to the GMP regulations for sterile pharmaceuticals, microbiological testing, and quality control testing.
- Maintain a working understanding of appropriate regulatory guidance, international pharmacopeias, ICH, established business processes and protocols, and applicable standard operating procedures.