Quality Assurance and Regulatory Affairs Supervisor

Dosecann Cannabis Solutions - Charlottetown, PE (30+ days ago)

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About the Company:
Dosecann is a Canadian licensed dealer dedicated to developing Cannabis Solutions for the global cannabis industry. Dosecann has assembled a world-class team housed in a purpose-built, 52,000 sqft. GMP compliant facility that will be the hub for cannabis extraction, product innovation and formulation.

Overview:
Based out of Charlottetown, Prince Edward Island, Dosecann LD. is currently looking for a Supervisor, Quality Assurance and Regulatory Affairs to join our Charlottetown team. Reporting to the VP, Domestic and International Supply Chain at Auxly, the ideal candidate aspires to work in the growing cannabis field with an award-winning team!

The successful candidate will be responsible for implementing and managing documents to fill in logs accordingly. The successful candidate will oversee implementation of Change Management, Quality Management System (QMS) e.g. guidance on Standard Operating Procedures (SOP’s) completion for production, maintenance, and health and safety practices to ensure all regulations and internal protocols are being adhered to.

Responsibilities:
Embodying Auxly and Dosecann LD.’s business mission and strategy and act in a responsible, ethical, and honest behaviour 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

Qualifications:
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 computer skills including the use of ERP system, Microsoft Office Suite, Adobe Acrobat and Google applications.
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.

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Dosecann. is an equal opportunity employer and encourages applications from all qualified individuals. We thank all applicants for their interest, however, only those selected for an interview will be contacted. We provide accommodation for job applicants with disabilities during the recruitment process in accordance with applicable laws. Please contact us to request accommodation.