Quality Assurance and Regulatory Affairs Supervisor

7 months ago

Leamington, Canada Auxly Leamington Inc. Full time

Auxly is currently recruiting for the following role;
**Quality Assurance and Regulatory Affairs Supervisor**

**What can you expect to do**:

- Embodying Auxly's business mission and strategy and act in a responsible, ethical, and honest behavior while consistently leading by example.
- Providing support for maintenance and retrieval of documents/ information from document management systems; providing expertise to operational teams regarding electronic record submissions.
- Contributing to the creation or update of standard operating procedures, forms, and work instructions.
- Reporting monthly trends on non-conformances (NC) to Site Quality Directors and Regional management. Lead and guide on completion of NC and CAPA processes. Review and provide coaching to operations team to complete non conformance reports and CAPA’s in a timely manner.
- Providing technical leadership and vision ensuring that operations are conducted in accordance with standard operating procedures pertinent to business needs and implement change controls to optimize regulatory performance.
- Liaising with department managers to ensure Change Management, Quality Management System, Preventative Maintenance, Installation Operational Qualification, and validation programs are being incorporated and maintained.
- Managing employee training programs, material files/equipment files and liaising with purchasing and production staff to assess incoming production materials for suitability in facility.
- Preparing for and participate in internal and external quality audits in conjunction with the Quality and Regulatory Departments.
- Promoting a healthy and safe work environment.
- Other tasks within the Regulatory Affairs, Operations and Quality departments as required.

**What we are looking for**:

- 3+ years of experience in effectively managing and leading teams in quality or operational role in the pharmaceutical or food manufacturing industry. Familiar with ISO-9001 regulated environment and practice.
- Ability to work independently, prioritizes multiple projects, addresses multiple issues, and handles multiple deadlines, in a hands-on environment.
- Self-motivated with a high degree of initiative and sense of urgency.
- Experience in writing SOP’s, deviations, investigations, non-conformances and change management controls.
- Previously demonstrated solid decision-making, training, and monitoring skills.
- Strong management and leadership skills along with strategic thinking ability, and a proven track record of GMP compliance and regulatory successes.
- Effective communicator, ability to multitask, analytical and attention to detail. Excellent written and oral communication skills.

**What will set you apart**
- An advanced or additional post-secondary degree or certification
- e.g. P.Eng.
- Previous experience in a manufacturing, cannabis company, or in an environment regulated by Health Canada.
- Previous experience using Sage X3.
- Auxly Leamington Inc. is an equal opportunity employer and is committed to providing employment in accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act (AODA). If contacted for an employment opportunity or testing, please advise Human Resources if you require accommodation._

**Job Types**: Full-time, Permanent

**Benefits**:

- Dental care
- Extended health care

Schedule:

- 8 hour shift

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- Cannabis Industry: 2 years (preferred)

Work Location: In person

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