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Aurora is a global leader in the cannabis industry serving both the medical and consumer markets. Headquartered in Edmonton, Alberta, Aurora is a pioneer in global cannabis dedicated to helping people improve their lives. The Company's brand portfolio includes Aurora, Aurora Drift, San Rafael '71, Daily Special, AltaVie, MedReleaf, CanniMed, Whistler, and Reliva CBD. Providing customers with innovative, high-quality cannabis products, Aurora's brands continue to break through as industry leaders in the medical, performance, wellness and recreational markets wherever they are launched.

 

QUALITY ASSURANCE VALIDATION ASSOCIATE

Location: Bradford, ON

 

Aurora Cannabis Inc. is currently recruiting for a Quality Assurance Validation Associate to join our Bradford, Ontario facility. The employee will report to the Manager, Quality Assurance - River.

MAIN RESPONSILBITIES:

  • Promote positive safety culture through participation, and adherence to, HSE programs
  • Promote positive working relationships with all departments
  • Understand, interpret, and apply regulatory, GACP, GPP and GMP requirements
  • Act as an ambassador for regulatory and process compliance
  • Maintain knowledge of applicable standards, regulatory requirements, and statistical methods
  • Liaise with supports and stakeholders to ensure qualification/validation expectations met
  • Liaise with external supports or vendors, where appropriate, for added technical guidance
  • Provide training and guidance to stakeholders as it relates to validation and validation execution
  • Maintain and continuously improve validations program and key inputs, mainly:
    • Prepare validation training for indirect and direct stakeholders
    • Write, maintain, and continuously improve in-scope SOPs
    • Maintain requalification/revalidation plan, including exemptions and justifications
    • Develop equipment performance (re)qualifications, and process (re)validation protocols
    • Develop cleaning validation protocols and risk assessments
    • Ensure the compliant execution of all validation protocols
    • Create flow diagrams and value stream mapping where required
    • Prepare detailed reports on the outcome of the qualification/validation
    • Identify deviations from established procedures/equipment standards
    • Make recommendations for process-adjustments post-execution where required
    • Review/approve IOQ/FV protocols
    • Maintain overview of equipment set-points and equipment process set-points
    • Complete validation impact assessments as part of change management
    • Maintain qualification and requalification plans
  • Other duties as assigned, including but not limited to: back-up to other departmental roles

 

QUALIFICATIONS:

  • Organized, systems-oriented thinker with a strong understanding of continuous improvement
  • Previous experience in process design, flow mapping, writing, and conducting process validations and equipment performance qualifications.
  • Demonstrated ability in project management and project management tools.
  • Strong computer skills (Word, Excel, PowerPoint, Visio, etc.).
  • Exceptional listening, communication, analytical and problem-solving skills.
  • Ability to handle multiple priorities and a dynamic changing environment.
  • Able to bring innovative solutions to process and equipment design and flow mapping.
  • Flexible, adaptable, and previous experience in a fast-paced environment.
  • Able to travel between Aurora locations.
  • Degree or diploma in a relevant field, such as: Pharmaceuticals, Biotechnology, Engineering, Manufacturing, Quality Assurance, Quality Control, Laboratory Sciences Certification as a Quality Engineer, Process Analysis, Continuous Process Improvement, LEAN or Six Sigma considered an asset.
  • 1 to 3 years of experience in Validation, with experience in equipment qualification, process, and cleaning validation
  • 2 to 5 years of experience of working in Production/Quality department in pharmaceutical manufacturing environment
  • Familiarity with regulatory requirements with respect to validation and qualification activities in pharmaceutical industry
  • Certification in Project Management, while not required is considered an asset
  • Knowledge of GMP, and Health Canada regulations.
  • Analytical, problem solving, and decision-making skills.
  • Proficient with standard office technology such as Microsoft Office and ERP systems

 

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

 

Aurora is an equal opportunity employer. At Aurora, we are committed to do business inclusively and accommodate applicants with disabilities. If you require accommodation (including, but not limited to, an accessible interview site, alternate format of job posting) during the recruitment and selection process, please let our Recruitment team know.


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