Quality Assurance Manager
Primary Job Responsibilities:
• Oversee the following Quality Management sub-systems:
Incoming raw material controls and QC inspection and in process QC checks
Change control management,
Quality risk management,
Quality training and competency
• Participate in analytical investigations of out-of-specification, including: examine results, change control requests when necessary, generate deviation reports, determine root causes, and provide recommendation for corrective actions
• Support continuous quality improvement initiatives including but not limited to implementation and maintenance of risk management, product quality, auditing, key performance indicators
• Design, write, review and approve SOPs including assurance of compliance to ACMPR, QMS, ISO, and GMP
• Final batch review and release, including review of analytic, and microbial results, and facility conditions deviations and change controls
• Guide and advise CAPA review & approval
• Ensure investigation & annual product review are conducted in a compliant matter
• Oversee the management of the Complaint program to ensure all critical trends are addressed appropriately and investigations are handled.
• Oversee and direct raw material control system
• GMP, GPP, GDP, ISO training of new and ongoing staff as required
• Efficiently & effectively make accurate assessments of failures to correct root cause to ensure continuous improvement
• Hire, develop, train, support and empower Quality personnel to assist them with their individual development goals
• Provide guidance to the all other areas of the facility with respect to GMP, ISO and ACMPR compliance
• Stay on top of current trends and innovations in Quality
• Advises management group of any situation that may need attention or warrant management involvement
• Liase with cultivation, processing and other internal stakeholders to implement and support various quality programs
• Establish & oversee the maintenance of administration activities required for operational effectiveness of Quality department such as budgeting and resource planning
• Where applicable, must adhere to MedReleaf’s SOPs and comply with Health Canada’s Access to Cannabis for Medical Purposes Regulations (ACMPR). In addition, must adhere to ISO 9001:2015 (Quality Management System), ISO 14001 (Environment Management System) and OHSAS 18001 (Occupational Health and Safety Assessment Series).
• Actively and proactively engage in the ongoing management and improvement of MedReleaf’s quality system.
• Where applicable, promote and maintain GMP requirements.
• Other duties as required