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    Quality Assurance Associate - Melbourne, Australia - Canopy Growth

    Canopy Growth
    Canopy Growth Melbourne, Australia

    4 days ago

    Default job background
    Full time
    Description

    The Opportunity

    Canopy Growth is looking for a Quality Assurance Associate/Facilitator to join our team. As a QA Associate, you will be reporting to the Director, Quality Assurance & Regulatory Affairs and will be instrumental in supporting our growth within the ANZ region, ensuring our products exceed expectations. You will engage with a wide variety of stakeholders, sometimes internationally, and enjoy being part of a fast moving, young and evolving medicinal cannabis industry.

    Responsibilities

  • Collaborate with Quality Control, Regulatory Affairs, Operations, Medical and Marketing departments to ensure compliance with applicable regulations and guidelines of regulatory authorities such as: Therapeutic Goods Administration Office of Drug Control State Departments of Health
  • Plan, execute, and oversee product inspection and testing for quality and conformance to specifications and deliverables, largely through third party service providers
  • Collate and investigate reports of product and device quality issues and ensure resolution in accordance with company guidelines and regulatory requirements
  • Collate and report adverse event reports in accordance with company guidelines and regulatory requirements
  • Develop or update procedures and databases for capture, investigation, and documentation of product complaints and adverse events
  • Develop, author and review standard operating procedures and related records and facilitate the same for other departments
  • Supports the import and distribution of Schedule 4/8 products and raw materials
  • Assisting in the specification, review and approval of input materials.
  • Through in-house training become the resident expert in the electronic documentation control system
  • Prepares and supports management reviews of process performance related to product quality and of the quality management system
  • Supports, reviews/audits and follows documented procedures to ensure that service providers and outsourced activities are approved and monitored
  • Escalates issues in a timely manner to the Director of Quality Assurance & Regulatory Affairs
  • Other duties as required

    • Experience

  • Post secondary qualification in a relevant life sciences field with at least 2 years' experience in a Pharmaceutical or medical device manufacturing environment
  • Demonstrated understanding of the TGA Code of GMP, PICs Guide and/or ISO14385
  • Basic knowledge and understanding of Pharmaceutical Quality (i.e. document management, batch release, audits, change control etc), equipment and method validation, sample preparation, analytical techniques & data management
  • Demonstrated knowledge of Quality Systems as they relate to pharmaceuticals or medical devices
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