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Manager, Quality Systems (Change Control & Documentation)

Full Time

Career Connections Canada Inc.

"Connecting great people with great companies"

The main responsibility for this position is to participate in the maintenance of a site wide quality program to meet company, Canadian and FDA GMP requirements.  This position acts to manage designated Quality Systems to support product manufactured, packaged or tested at the manufacturing facility.

Duties and responsibilities

  • Provide QA Oversight to the initiation of Change Controls.
  • Review activities performed for change controls to ensure all necessary activities have been appropriately executed prior to approving closure of the change.
  • Oversee change controls presented by customers and suppliers to ensure that the impact of the proposed changes is accurately interpreted.
  • Providing training and coaching to designated employees in other departments as to the requirements for Creating and evaluating the impact of proposed changes.
  • Provides oversight for all activities required to fully support one or more Quality Systems.
    • Annual Product Quality Review
    • Vendor Quality Management
    • Customer Quality Management
    • Documentation System
    • Change Control System
    • Internal Audit Program
    • Site Training Program
    • Stability Program
  • Works with other departments to proactively build quality into the processes and systems.
  • Oversight of the GMP Documentation System and training program.
  • Manage and coordinate timely and effective completion of routine documentation and change control tasks through the planning and assigning of responsibilities.
  • Manages the electronic training system (eKA) and provides training, as required, on its use.
  • Schedule and to prioritize tasks involving Documentation systems to promote efficient use of time.
  • Train, coach and supervise Associates towards process and performance improvement.
  • Prepare and enhance Standard Operating Procedures related to responsible Quality System.
  • Review and approval of reports/data generated by Quality Systems Associates
  • Official designate for Quality Systems Senior Manager
  • Generate metrics associated with individual quality systems/programs.
  • Active participation in Customer and Regulatory Inspections
  • Generate, gather and analyze data to support specified Quality System.
  • Automates job functions to achieve efficiency improvements.
  • Identifies and implements key process improvements to enhance systems, gain site efficiencies and elevate GMP requirements.
  • Additional duties as assigned.

Qualifications

  • Requires Bachelor’s Degree in Science, or related discipline.
  • Minimum 10 Years’ experience in the Pharmaceutical industry with at least 5 years in a Quality role
  • Demonstrated understanding of all the above listed Quality Systems.
  • Sound knowledge and application of Health Canada and FDA regulations
  • Ability to influence others to do things while maintaining integrity and trust, by keeping a continuous focus on effective communications to ensure achievement of shared goals.
  • Excellent written communication and report writing skills.
  • Strong organizational skills and ability to multi-task; detail oriented.
  • Strong negotiation, and training skills, required to ensure that quality requirements are maintained while also meeting business expectations.
  • Participation in investigations involving deviations to procedures or systems with logic, data, and corrective measures.
  • Implement short range continuous improvement strategies towards enhancing the quality standards of the department and facility.

 

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