Quality Assurance

4 weeks ago

Mississauga, Canada Radiant 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 **Quality Assurance & Regulatory Affairs Manager **to join Radiant and be part of our dynamic team.

**CONTRACT POSITION: This is a 14-month contract with the possibility of extension.**

**HYBRID WORK MODEL with TRAVEL REQUIRED: Flexible schedule required. This position includes some remote work from home AND 60% GTA travel to our Mississauga, Brampton and Bolton warehouses.**

**Use of personal vehicle required (mileage paid).**

**What You’ll Do**:

- Maintain a compliant food and drug GMP Quality System.
- Manage a team of 3 employees.
- Manage all recalls.
- Compile APQR’s.
- Ensure employees are trained on respective SOP’s and applicable regulations at each facility.
- Keep management advised of changes in Good Manufacturing Practices (GMP) requirements, AIB regulations, SFCR, Medical Device regulations, Natural Health Products regulations and any other applicable regulations.
- Keep current on new regulatory requirements from CFIA and Health Canada, working with advisors as required. Plan and implement the required changes working with all stakeholders.
- Liaise with Health Canada and CFIA in order to resolve regulatory issues and ensure continued compliance, with the support of advisory organizations.
- Provide Quality Expertise during the assessment of new opportunities, working with Sales and Customer Service for timely launch of services with attention to regulatory issues.
- Work with customers to ensure that their products meet Health Canada regulatory requirements.
- Support Quality Advisors in the preparation, submissions, supplements and amendments to the licenses required by new customers.
- Ensure warehouses are prepared for audits with regulatory authorities.
- Participate in external and regulatory customer audits. Lead internal audits. Ensure that non-conformances are addressed in the required timeframe.
- Develop and implement tools for maintenance and management of the regulatory affairs system. Ensure proper documentation to track and maintain compliance.
- Assist in the development of functional business specifications. Work with IT to deploy associated software tools.
- Provide IT support where required to ensure adequate validation of software associated with GMP requirements.
- Provide tracking and support for the Billing of Quality and Regulatory services, including the review and authorization of services acquired to deliver the Quality Management programs
- Other duties and assignments as required.

**What You Bring to the Role**:

- Bachelor of Science degree (B.Sc.) e.g. Chemistry, Biology, Chemical Engineering or in a similar area.
- Minimum 5 years’ experience in a quality assurance and regulatory affairs role of which a minimum of 1 year must be in a management role.
- Expert knowledge of AIB Prerequisite and Food Safety Program for Distribution Centres
- Experience in GFSI-recognized food safety systems
- Experience in Food Defense and FDA licensing requirements.
- Proficient in Microsoft Office i.e. Outlook, Word, PowerPoint, Visio.
- Intermediate computer skills required in Excel i.e. filter, sort, formulas, graphs.
- Experience with Quality Management Software is an asset.
- Dedicated commitment to providing superior, timely internal and external customer service.
- Strong interpersonal skills with the ability to communicate clearly and effectively in verbal and written form with all levels of the organization.
- Strong problem-solving and decision-making skills.
- Highly organized with the ability to multi-task.
- Ability to assemble and lead teams through problem resolution activities.
- Team cooperation and respect is required.
- Analytical and detail-oriented.
- Work well under pressure in a time sensitive environment.
- Ability to travel as required within GTA (60%).
- Ability to travel within Canada (10%).

**The Fine Print**:
Schedule:

- Day shift
- Monday to Friday

Application question(s):

- Are you comfortable with a hybrid work model that includes travel to our Brampton, Bolton and Mississauga warehouses.
- Are you interested in working a 14-month contract position (this is not a consultancy position)
- What is your annual salary expectation for this position

**Education**:

- Bachelor's Degree (required)

**Experience**:

- Health Canada Audits: 1 year (required)
-

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