Careers

Mississauga, Ontario

Quality Engineer -Validation Specialist

Quality Engineer -Validation Specialist
Alliston, ON
Full-time

SUMMARY OF RESPONSIBILITIES

  • · Coordinate and execute the validation program to ensure the facility and all equipment, processes and systems are in a validated state of control, by maintaining Validation Master Plans, creating/compiling and/or reviewing validation packages, providing technical expertise and information resources to other departments and ensuring compliance to Regulatory and Corporate requirements.
  • · Ensure that validation protocols are written, executed, and documented in accordance with Corporate Quality Policies, Health Canada, and ISO requirements.
  • ·Utilize the Trackwise system for Change Control Management practices
  • Create validation packages for systems, processes, cleaning procedures, analytical methods and equipment to demonstrate a validated state of control
  • Write protocols, manage the execution of validation testing plans by liaising with other departments to coordinate validation activities, compile and analyze data, perform statistical analysis and prepare validation packages
  • Coordinate validation and IQ/OQ/PQ activities with Production, Quality Control Laboratories and outside contractors providing leadership, training and guidance
  • Monitor and support the execution of the protocols through training, facilitating and problem solving activities
  • Provide guidance and assistance on validation formats, requirements and procedures as a team member on various validation projects
  • Support validation training for team members and provide resource information as a technical expert
  • Review completed validation packages for compliance with validation requirements
  • Manage the validation status of the facility and ensure change control by maintaining the facility Master Plan as a current document, and tracking all validation efforts via schedules & status logs
  • Maintain the Site Reference File
  • Establish and manage the Validation Maintenance schedule
  • Prepare or assist in the preparation of Validation Maintenance packages
  • Manage the cleaning validation program and update the Cleaning Validation Risk Assessment document, adding new products and equipment as required
  • Establish and manage the Validation Maintenance schedule
  • Prepare or assist in the preparation of Validation Maintenance packages
  • Manage the cleaning validation program and update the Cleaning Validation Risk Assessment document, adding new products and equipment as required
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Our Advisor for this position

Wandalin Jana

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