Qra (Quality Assurance & Regulatory Affairs)

4 weeks ago

Bolton, Canada Radiant Canada Full time

Radiant offers a complete range of industry-leading transportation and warehousing solutions to businesses around the globe by leveraging our extensive network of carrier partners across all modes. Radiant provides customized logistics solutions that create value and increase profitability for our customers.

Radiant Canada is a learning environment in which passion, dedication and a commitment to getting the job done are valued. That’s what being on our team is all about. It’s where you can gain valuable skills and experience, which also helps Radiant grow. If this sounds like the kind of company you are looking for, we would love to hear from you

We are currently looking for a **QRA (Quality Assurance & Regulatory Affairs) Specialist 6 MONTH CONTRACT **to join Radiant and be part of our dynamic team.

**HYBRID WORK MODEL: Work in the office at 12480 Coleraine Dr, Bolton, ON L7E 4M2 every Monday and Wednesday. Work from home Tuesday, Thursday and Fridays.**

**What You’ll Do**:

- Ensure Licensing, GMP, and Food Safety requirements are met.
- Maintain a compliant drug GMP Quality System.
- Handle and assist manufacturers with recalls.
- Review and assess APQR’s provided by the manufacturers for whom the Company imports goods. Ensure APQR’s contain the key elements required by Health Canada’s GMPs. Work with manufacturers to rectify.
- Obtain and assess regulated product stability, process validation, test method validation, master documents, full batch records, labels, specifications and API information.
- Review master documentation provided by the manufacturers for whom the Company imports goods. Identify any deficiencies in the process / documentation as it pertains to compliance. Work with manufacturers to rectify.
- Review batch documentation provided by the manufacturers for whom we import. Arrange for necessary drug product testing through a licensed laboratory. Compare results obtained from the laboratory to those provided by the manufacturer in original Certificate of Analysis (C of A). Investigate any discrepancies with the lab and manufacturer. Once all issues have been resolved, sign off on release of product to remove it from quarantine and allow for distribution.
- Execute QA hold and release function.
- Create, review and update internal SOPs as necessary to ensure GMP compliance.
- Conduct ongoing review of existing products that the Company distributes to ensure regulatory compliance i.e. label review, registrations, etc.
- Review new products that are received from manufacturers to ensure that all necessary registrations are in place with Health Canada.
- Review and assess returned finished goods received from customers.
- Review complaints in conjunction with customers. Assist with resolution.
- Manage the collection, processing, and reporting of adverse events (AEs)
- Review and submit adverse events, product complaints, and all other safety information within the required timeframes.
- Obtain Annual Summary Reports from Market Authorization Holders and ensure key elements from Health Canada’s GVPs are included in these reports.
- Assist with the development of the Quality Management System in support of the Regulatory
- Affairs requirements.
- Provide advice to existing and potential customers on applicable regulatory issues.
- Conduct regular self-inspections of the facilities and, when necessary, conduct inspections of contracted laboratories and Quality Consultants.
- Provide Food Safety, GMP compliance and SOP training to employees.
- Communicate Food Safety and Regulatory Affairs requirements to executives and customers when onboarding new customers.
- Work with various operational teams to ensure that high Food Grade standards are maintained at all facilities.
- Provide recommendations for continuous improvement initiatives as it relates to quality and regulatory affairs.
- Act as the primary contact during Health Canada inspections. Coordinate internal teams and implement corrective actions to completion.
- Organize and conduct mock recalls to test the integrity of processes and systems to meet Health Canada requirements.

**What You Bring to the Role**:

- University Degree in Biological Sciences or related discipline.
- Diploma in Regulatory Affairs is a definite asset.
- Minimum 3 years’ experience in Canadian and/or US Regulatory Affairs in Food, Pharma, Medical Devices, and Natural Health products.
- Experience in GMP (Importation / Distribution), drug establishment licensing, and natural health product site licensing.
- Experience in AIB and other GFSI recognized Food Safety certification systems (for distribution centers is an asset).
- Experience in Supply Chain (transportation, logistics, warehousing) is a definite asset.
- Dedicated commitment to ensuring customer requirements for licensing are proactively managed.
- Strong interpersonal skills with the ability to communicate clearly and effectively in verbal and written form to all levels.
- Highly o

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