Quality Assurance Manager

OPTALENT | CANADA
Posted on 12 December 2021

Information

Industry Manufacturing
City Brampton East
Code postal L6T 1C1
State Ontario
Required experience
Salary $75,000 - $95,000

Description

Our client, a leader in the pharmaceutical industry is looking for a Quality Assurance Manager to join their operations

Job Purpose

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

Duties and Responsibilities

  • Design, implement and maintain an effective and robust site Change Management Program
  • Map all the tasks and activities associated with each type of the change and ensure alignment with the site functional stakeholders
  • Ensure that all the changes have been executed by their owners effectively including risk-based impact of the change
  • Provide QA Oversight to the initiation of Change Controls and ensure their timely evaluations and approvals
  • Review activities performed for change controls to ensure all necessary actions 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 are accurately interpreted
  • Design, develop, own and maintain site Change Control Training Program
  • Provide training and coaching to designated employees in other departments as to the requirements for creating and evaluating the impact of proposed changes
  • Ensure appropriate design and users access roles of the electronic tools employed for the Change Control Program execution
  • Provide support and necessary information to the following Quality Assurance Programs and Systems:
    • Annual Product Quality Review Program
    • Vendor Quality Management Program
    • Documentation Management System
    • Internal Audit Program
    • Site Training Program
    • Stability Program
  • Execute reports and metrics for monthly Site Quality Council, Quarterly Business Review (QBR) Meetings
  • Lead site Change Control Board meetings
  • Work with other departments to proactively build quality into the processes and systems
  • Manage and coordinate timely and effective completion of routine documentation and change control tasks through the planning and assigning of responsibilities
  • Manage updates associated with site SOPs into the electronic Learning Management System (eKA, LMS etc.)
  • Ensure updates to the role curriculum associated with the SOPs changes
  • 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 approve reports/data generated by Quality Programs Team Associates
  • Official designate for Senior Manager, QA (Programs)
  • Actively participate in Customer and Regulatory Inspections
  • Generate, gather and analyze data to support specified Quality Programs and Systems
  • Automate job functions to achieve efficiency improvements
  • Identify and implement 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 of experience in the Pharmaceutical industry with at least 5 years in a Quality role
  • Demonstrated understanding of all of 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

Package includes:

  • A safe and clean; GMP regulated work environment
  • Opportunities for career growth and development
  • A competitive wage/salary
  • Incentive bonus programs that are designed to reward employees for their individual contributions
  • Benefit programs designed to support our employees and their families, including a comprehensive health & dental benefits package, group RRSP matching program, direct access to healthcare and well-being programs, and paid time off
  • Employee training and organizational development programs including tuition reimbursement, internal mobility programs, and employee recognition programs

Contact us now

for an assessment of your needs

1 866 798-9992
[email protected]

Montréal

Québec

Toronto


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