Quality Assurance Specialist
1 week ago
Juno Pharmaceuticals is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.
Key Responsibilities- Quality Management System: Support the digital transformation of our quality management system, ensuring seamless integration with our existing processes.
- SOP Development and Maintenance: Create, revise, review, and enforce Standard Operating Procedures (SOPs) to support operational activities, ensuring compliance with regulatory requirements.
- Training and Development: Lead the enhancement and maintenance of training materials to provide effective SOP and Good Manufacturing Practice (GMP) training to our staff.
- Method Transfers and Validations: Develop strategies to achieve method transfers and validations at our local labs, facilitating product launches and confirmatory testing.
- Product Dispositions: Perform dispositions of drug products to the Canadian market, ensuring compliance with Health Canada regulations and our SOPs.
- Annual Product Quality Review: Review Annual Product Quality Review and Yearly Biologic Product Reviews generated by our quality assurance department and partners, ensuring compliance with marketing authorization.
- Product Complaints: Document, report, investigate, and respond to product complaints, ensuring timely resolution and customer satisfaction.
- Vendor Qualification: Support the vendor qualification program by performing onsite, virtual, and/or desk-based audits of our GMP service providers.
- Quality Oversight: Support the quality oversight of pharmaceutical manufacturing, packaging/labelling, and testing deviations/non-conformance investigations and CAPA implementation at Contract Manufacturing Organizations (CMOs) and internally.
- Process Control and Product Dispositions: Identify non-conformances, initiate investigations, and lead the impact assessments to support process control and product dispositions.
- Regulatory Compliance: Lead the maintenance of our drug establishment licence foreign building annex, Table A, and GMP evidence of foreign buildings, ensuring compliance with regulatory requirements.
- Change Control: Perform quality assurance impact assessment for internal and third-party related change control records.
- Regulatory Audits: Support in any regulatory or third-party audit of Juno Pharmaceuticals as required.
- USP and BP Monitoring: Proactively monitor USP and BP for monograph updates and prepare for implementation.
- Education: University degree (B.Sc. or higher) in Chemistry, Biology, Biochemistry, or Health Sciences.
- Post-Graduate Certification: Post-Graduate Certification in Regulatory Affairs and Quality Assurance preferred.
- Regulatory Knowledge: Detailed knowledge of Canadian Food and Drugs Act and Regulations, Health Canada guidance documents, ICH guidance documents, GMPs, and other relevant guidelines with a focus on sterile injectables used in a hospital setting.
- Experience: Minimum 5 years relevant Canadian experience in a pharmaceutical quality assurance or compliance role with external audit experience.
- Skills: Proactive with a high degree of self-discipline, drive, and ability to work remotely or on-site with minimum supervision. Excellent communication skills to effectively interact with internal and external cross-functional teams. Excellent in Microsoft Office Suite and Adobe Acrobat.
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