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MANAGER, QUALITY ASSURANCE

 

MAIN RESPONSIBILITIES:

 

  • Oversee the following Quality Management sub-systems:
      • Non-Conformance reporting,
      • Incoming raw material controls and QC inspection and in process QC checks
      • Change control management,
      • Documentation management,
      • Planned deviations,
      • Quality risk management,
      • Quality training and competency
  • Participate in analytical investigations of out-of-specification values, 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 Health Canada, QMS, ISO, and GMP
  • Be the facility’s Health Canada security cleared Quality Assurance Person (QAP)
  • 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 and ISO 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, product development 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

 

GMP RESPONSIBILITIES:

 

  • Approve or reject, as appropriate, starting materials, packaging materials, intermediate, bulk and finished products
  • Ensure that all necessary testing is carried out and the associated records evaluated
  • Approve specifications, sampling instructions, test methods and other Quality Control procedures
  • Approve and monitor any contract analysts
  • Ensure the qualification and maintenance of department, premises and equipment;
  • Ensure that the appropriate validations are done
  • Ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need

 

 

ADDITIONAL RESPONSIBILITIES:

 

  • Where applicable, must adhere to Aurora’s SOPs and comply with Health Canada’s Cannabis Act and Cannabis Regulations. In addition, must adhere to ISO 9001:2015 (Quality Management System), ISO 14001:2015 (Environment Management System) and ISO 45001:2018 (Occupational Health and Safety Assessment).
  • Actively and proactively engage in the ongoing management and improvement of Aurora’s quality system.
  • Where applicable, promote and maintain GMP requirements.
  • Other duties as required

 

 

JOB REQUIREMENTS:
 

  • (5) Five or more years of QA experience in the pharmaceutical/nutraceutical or medical laboratory science related industry
  • A Canadian (or assessed as equivalent) B.Sc. degree or equivalent in an applicable discipline of science (chemistry, biochemistry, microbiology, chemical engineering, medicine, horticulture, medical laboratory science or related)
  • Experience in a Drug or Natural Health Care product manufacturing environment considered an asset
  • Ability to implement and maintain a Quality Management System including: batch record review, batch release, document control, complaints investigation, and CAPA including quality investigations
  • Fluency in MS Office is mandatory
  • Competency of technological writing (SOPs, Annual Reports, Investigation Summary)
  • Must be a proactive leader and an innovative thinker when making operational recommendations
  • Ability to work independently, with a strong attention to detail
  • Previous experience in a leadership role is required/mandatory – strong people-management skills are essential
  • Ability to speak and write in English 
  • Must be able to be approved as the QAP by Health Canada

 

QUALIFICATIONS:

 

  • Certification in any of the following: Quality Management, Laboratory Quality Management, Risk Management, Quality Improvement, LEAN, Six Sigma is considered an asset
  • Experience in a high volume, highly complex service, product, pharmaceutical or laboratory environment all through not required is a plus
  • Proven track record of developing, implementing and monitoring Quality initiatives into operational workflows
  • Bilingualism although not required, is considered an asset

 

We would like to thank all applicants for their interest but only those selected for an interview will be contacted.

 

Aurora Cannabis Inc. is an Equal Opportunity Employer.

 

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