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QUALITY ASSURANCE, VALIDATION ASSOCIATE

MAIN RESPONSILBITIES:

  • Develop equipment qualification and process validation plans, protocols, flow diagrams, test cases).
  • Create and maintain Cleaning Validation protocols and risk assessments.
  • Assists in the execution of qualification/validation protocols for production equipment, process validation and cleaning validation
  • Provide training specific to validation protocol requirements for sampling, to the production department
  • Write Standard Operating Procedures on validation and qualification methods.
  • Create process flow charts and value stream mapping, including critical risk factors, inputs and outputs.
  • Conduct process validations and equipment qualifications on new or existing processes or equipment in accordance with internal protocols and external standards (GMP, , Health Canada).
  • Apply statistical methods (as required) in process validations and equipment qualifications
  • Collaborate with internal stakeholders to ensure equipment is qualified/re-qualified and processes are validated/re-validated as required and according to schedule.
  • Identify deviations from established process or equipment standards and provides recommendations for resolving deviations.
  • Participate in internal or external training programs to maintain knowledge of validation and qualification principles, industry trends, or novel technologies.
  • Assist in training equipment operators or other staff on validation and qualification protocols.
  • Design validation study features, such as sampling and testing.
  • Collaborate with all stakeholders (QA/QC, R&D, Operations, Laboratory, Product Development etc.) to ensure validation and qualification needs are met.
  • Prepare detailed reports or design statements, based on results of validation and qualification tests or reviews of procedures and protocols.
  • Resolve testing problems by modifying testing methods or revising test objectives and standards
  • Collaborate with external vendors as required.
  • Conduct audits in collaboration with the Quality audit team of validation or qualifications to ensure compliance to GMP, and Health Canada.
  • Other duties as assigned.

 

 

QUALIFICATIONS:

 

  • Systems and process thinker who understands the importance of continuous improvement and how it fits within the Quality Management System and Risk Management.
  • Previous experience in process design, flow mapping, writing and conducting process validations and equipment qualifications.
  • Demonstrated ability in project management and project management tools.
  • Strong computer skills (Word, Excel, PowerPoint, Visio, etc.).
  • Must be well organized.
  • 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.
  • Strong relationship-building capabilities.
  • Collaborative, team-oriented and versatile.
  • 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 a plus.
  • Knowledge of GMP, and Health Canada regulations.

 

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.