The Quality Assurance Person (QAP) is accountable for the development, implementation and ongoing monitoring of the quality assurance and control systems in compliance with the Cannabis Act. The Quality Assurance Person (QAP) must have strong leadership qualities and the ability to liaise with internal and external departments. Key Responsibilities
Ensure all production, packaging and labelling activities are conducted according to applicable legislation including but not limited to GPP, GMP and cannabis regulations
Review and approve Standard Operating Procedures (SOPs), Work Instructions, Forms and Master Batch Record (MBR) documentation
Ensure all production, packaging and labelling activities are carried out according to approved Standard Operating Procedures (SOP)
Assist with preparing reports required by the cannabis regulations
Review and approve labels for final cannabis products for accuracy and compliance with cannabis regulations
Serve as subject matter expert for all quality requirements in the manufacturing of cannabis products Establish and enforce quality assurance standards in cultivation inputs, processing and packaging of cannabis
Ensure all record keeping for methods and procedures are updated and current as per the Cannabis Regulations
Manage preparation and handling of mock/actual recall events.
Conduct and report quality complaint investigations, including adverse reactions
Evaluate the impact of change requests on product quality, quality management systems and regulatory compliance
Provide support for on-site audits/inspections conducted by external authorities Initiate corrective and preventive actions (CAPAs) and conduct investigations to address non-conformances, out-of-specification results, and ongoing/trending deviations, as needed
Oversee implementation of methods and procedures for inspecting, testing and evaluating the quality of cannabis and cannabis products
Assist with the Document Management System, document control, and SOP training
Support generation and management of Quality Agreements
Ensure only pest control products registered for use on cannabis under Pest Control Products Act (PCPA) are released for production use
Approve and release starting materials; packaging materials; intermediate, bulk and finished products Assist with inventory management
Establish and maintain good working relationships with vendors and third-party service providers.
Participate in improvement initiatives and special projects, as required
Manage, lead and motivate a team of individuals
Schedule team members and department activities appropriately Delegate departmental tasks accordingly
Support in the delivery of a meaningful performance management program
Qualifications and Skills Academic/Educational Requirements
Minimum of Bachelor\xe2\x80\x99s degree in related scientific field with regulatory discipline required or shows demonstrated experience in the required role.
2 - 5 years of education and/or experience in scientific field preferred.
Required Skills/Experience/Knowledge
QA experience in a GMP/GPP quality position in pharmaceutical or cannabis industry or equivalent is considered an asset
Health Canada Security Cleared
1-2 years of experience in preparing and writing standard operating procedures, test methods, sampling protocols or other quality management system documentation is considered an asset.
Strong scientific, analytical and mathematical skills.
Able to understand of sampling protocols, sampling plans, test method protocols, methodology, test method limitations, validation, risk assessment analysis and how to apply scientific rationale.
Able to understand and interpret laboratory test results, validation studies, stability protocols, and safety and efficacy studies.
Excellent verbal and written communication skills; and ability to clearly communicate requirements and provide direction to others in a manner that can be easily understood.
Excellent organization skills and the ability to adapt to changing priorities and deadlines.
Analytical thinker with excellent root-cause analysis and problem-solving skills.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Knowledge of cultivation, plant chemistry, and chromatographic techniques is considered an asset Regulatory Auditing
Able to work independently and efficiently with little supervision
Health Canada Security Clearance and work experience with a Canadian Licensed Producer (LP) is considered as an asset
Job Types: Full-time, Permanent Salary: $80,000.00-$95,000.00 per year Flexible Language Requirement:
French not required
Schedule:
8 hour shift
Day shift
Monday to Friday
Weekend availability
Ability to commute/relocate:
Edmonton, AB: reliably commute or plan to relocate before starting work (required)
Experience:
quality assurance: 2 years (required)
Work Location: In person Application deadline: 2023-04-11 Expected start date: 2023-04-03
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