Validation Specialist, Molecular Imaging and Therapy Quality Professional
3 weeks ago
Validation Specialist, Molecular Imaging and Therapy Quality
BC Cancer
Provincial, BC
This role will support the Molecular Imaging and Therapy Quality Program for BC Cancer – IAMI. The Validation Specialist will require on-site presence at the BC Cancer Centre, with remote work as appropriate.
Reporting to the departmental Quality Assurance Manager, the Validation Specialist supports the validation program within BC Cancer's radiopharmaceutical manufacturing laboratory as well as the manufacture, testing and development of Good Manufacturing Practices (GMP) compliant PET radiopharmaceuticals.
Key Responsibilities
- Draft and update validation protocols to ensure Health Canada regulatory compliance for equipment, analytical methods, and production processes, and submit to manager for approval.
- Ensure qualification and validation activities are scheduled appropriately in relation to the clinical manufacturing schedule in consultation with the Production Unit Manager, and executes validation activities in accordance with approved protocols.
- Orient radiochemistry staff on the Functional Imaging department's equipment, processes, and test method validation protocols to establish compliance with Health Canada GMPs. This includes ongoing coaching with respect to validation requirements and regulatory expectations.
- Keep current on regulations and guidance documents related to validation and qualification. Identify trends, best practices, and process improvement opportunities and coordinate their implementation to ensure continued compliance and efficiency of the validation program.
- Conduct root-cause investigations associated with deviations, non-conformances, and failures resulting from validation and qualification activities through interviews, process review and root cause analysis, summarize findings, and recommend follow-up and/or corrective action.
- Write final validation reports, including data analysis, discussion of results, and final conclusions. Submit reports to the Quality Assurance Manager, for review and approval, and for incorporation into the regulatory submission process.
- Prepare radiopharmaceuticals for clinical use following established procedures and Good Manufacturing Practices. Production activities are coordinated with the departmental Production Unit Manager.
Requirements
- A level of education, training, and experience equivalent to a Bachelor's degree in Chemistry or a related discipline.
- Three to five (3-5) years of experience in a pharmaceutical GMP manufacturing environment.
PHSA is committed to employment equity, encouraging all qualified individuals to apply. We recognize that our ability to provide the best care for our diverse patient populations relies on a rich diversity of skills, knowledge, background and experience, and value a safe, inclusive and welcoming environment.
Reconciliation is an ongoing process and a shared responsibility for all of us. The BC Governments' unanimous passage of the Declaration on the Rights of Indigenous Peoples Act was a significant step forward in this journey—one that all health authorities are expected to support as we work in cooperation with Indigenous Peoples to establish a clear and sustainable path to lasting reconciliation.
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Vancouver, British Columbia, Canada PHSA Full timeJob Title:Validation Specialist, Molecular Imaging and Therapy QualityJob Summary:We are seeking a highly skilled Validation Specialist to join our team at BC Cancer. The successful candidate will be responsible for supporting the validation program within our radiopharmaceutical manufacturing laboratory, ensuring compliance with Health Canada...
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