Summary
The Quality Assurance (QA) Specialist is responsible for the management and conduct of quality assurance activities at Lucy Scientific Discovery Inc. (LSDI) and subsidiaries to ensure the delivery of quality products and services, in compliance with applicable regulatory requirements. This position reports to the Chief Executive Officer (CEO) and/or designate.
Roles and Responsibilities
The following are the principal roles and responsibilities of the QA Specialist:
- Management and conduct of quality assurance activities of LSDI and subsidiaries to ensure compliance with applicable regulatory requirements including the Canada Controlled Drugs and Substances Act and applicable regulations related to psychotropics, Good Manufacturing Practices and other regulations and guidelines as applicable to the business operations of the company.
- Conduct of Quality Assurance activities including auditing, SOP management/document control, training and training program management, vendor qualification, archives and privacy.
- Develop and review Standard Operating Procedures (SOPs).
- Health Canada Dealer's License application and amendment activity management; management of industry-related regulatory licensing activities.
- Develop and implement corporate quality strategies and objectives for compliance with applicable regulations and guidelines.
- Perform staff training (e.g. quality, regulatory).
- Work with department management to ensure successful and effective implementation of SOPs and corporate quality strategies.
- Provide continuous quality oversight and regulatory guidance in all areas of business operations to ensure compliance with regulatory requirements.
- Facilitate regulatory (i.e. Health Canada) inspections and client audits; follow-up on corrective actions and respond to findings and queries.
- Sustain a corporate quality culture based upon accountability, teamwork, collaboration, and continuous quality improvement.
- Report the status of regulatory compliance and quality to the CEO and department heads/management on a regular and timely basis.
- Maintain current knowledge of the regulatory landscape to ensure that LSDI’s quality programs fulfill changing and evolving regulatory and client needs.
- Other duties as required.
Qualifications
Minimum level of education:
Post-secondary degree in a related scientific discipline or equivalent
Minimum level of employment experience:
5+ years of experience in a quality assurance role in a pharmaceutical GMP finished product and/or API manufacturing environment
Other Requirements:
Excellent management and interpersonal skills. Ability to interact professionally with diplomacy. Sound decision-making abilities based upon regulatory knowledge with business sensibilities
Working Conditions
There are no special working conditions
Physical Requirements
There are no special physical requirements.
Health and Safety Responsibilities
All employees shall work according to the provisions outlined in the Occupational Health and Safety Regulations in addition to the safety policies set forth at LSDI. All employees shall ensure that personal protective and safety equipment are appropriately used as required and that safety policies and SOPs are followed by employees.
