NEW JOB POSTING: Quality & Compliance Associate

Job Summary:

The Quality & Compliance Associate jointly with the Manager, Quality is responsible for the quality assurance, quality control and quality compliance activities in support of the importation and distribution of JPC’s drug products.

The Quality & Compliance Associate will assist in the operational oversight and perform activities relating to establishment licensing, document control, batch record review, product dispositions, vendor qualification, self-inspections, complaints, deviations, CAPAs, SOP writing, change control, process validation, analytical method validation/transfer and the fulfilment of post market commitments.

The Quality & Compliance Associate acts as a positive influence toward quality awareness throughout the organization. The position requires detailed knowledge of Health Canada Food and Drug Act, regulations and guidance documents. The successful candidate is detail oriented and is able to demonstrate problem solving skills to identify solutions. The role requires analytical thinking and exceptional time management abilities to progress multiple concurrent projects within established timelines.

Essential Responsibilities:

• Create/write, revise, review and enforce Juno’s SOPs as needed to support operational activities.

• Support creation of training materials and provide SOP/GMP training as needed.

• Organize analytical testing for JPC’s incoming finished goods.

• Release drug products to the Canadian market ensuring compliance to Health Canada regulations.

• Support the creation and maintenance of quality system records, document filing and archival.

• Compile Annual Product Quality Review and Yearly Biologic Product Reviews.

• Document and report receipt of product complaints.

• Support the vendor qualification program by assisting with onsite or desk audits of JPC’s GMP service providers.

• Support the quality oversight of pharmaceutical manufacturing, packaging/labelling and testing deviations/non-conformance investigations and CAPA implementation at CMO’s and internally.

• Support maintenance of JPC’s drug establishment licence, Table A and GMP evidence of foreign buildings.

• Perform quality assurance impact assessment for internal and third-party related change control records.

• Review JPC’s product labelling for regulatory compliance.

• Support in any regulatory or third party audit of JPC as required.

• Review and evaluate product returns for disposition and destruction requests 

• Perform additional duties as assigned by the Manager, Quality.

Qualifications:

• University degree (B.Sc. or higher) in Chemistry, Biology, Biochemistry or Health Sciences.

• Post-Graduate Certification in Regulatory Affairs and Quality Assurance preferred.

• Detailed knowledge of Canadian Food and Drugs Act and Regulations, Health Canada guidance documents, ICH guidance documents, GMPs and other relevant guideline with focus in sterile injectables.

• Minimum 0-3 years relevant Canadian experience in a pharmaceutical quality assurance or compliance role.

• 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.

Location:

• Located in Toronto (GTA)

This job description for the Quality & Compliance Associate outlines the primary responsibilities of the role and should not be considered a detailed description of all requirements that may be inherent in the job. 

How to Apply:

Please send us an email with your resume to careers@junopharm.com