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Validation Specialist

ALTEN Canada • Alliston, ON, CA • 16h ago

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
Contribute / participate in facility Quality review meetings
Participate as the Validation SME during Regulatory and Corporate compliance inspections
Support the Quality System Improvement Plan (QSIP) by ensuring that quarterly Quality Quotient assessments are completed and opportunities are identified and action plans created

Required Skills

Must-haves:
Experience with vision systems and equipment validation on the PLC side
Regulation & standards (FDA / Health Canada) knowledge

Preferred Skills

Tools / software / methodology / certification:
LIMS, Trackwise, Minitab
Soft skills:
Multitasker with a “can-do” or “make it happen” attitude;
Autonomous and has to be able to speak up and raise issues if observed. Be confident.
Seniority level:
3+ years of experience

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