Change Control Coordinator
Brevitas Consulting Inc.
Toronto, ON, CA
4d ago

Job Description

Resolute Workforce Solution (subsidiary of Brevitas Consulting Inc.) is dedicated to helping organizations achieve tangible results and lasting improvements via successful project delivery, continuous process improvement and effective management of change.

We serve businesses in a wide range of industries including Pharmaceuticals, Food & Beverage, Chemicals, and Information Technology.

We are looking for highly motivated and energetic Change Control Coordinator to join our team in the Greater Toronto Area.

RESPONSIBILITIES Initiate and manage change control requests affecting the Filling & Packaging department, including presenting change control requests to the change control board.

Collaborating with assessors from different functions within the Quality Department (quality, engineering departments) and outside (Regulatory affairs) for evaluation of changes.

Ensure timely closure of change controls, including follow up on actions under another departments' responsibility. Develop, revise and perform quality checks on documents and adhere to timelines within the Filling & Packaging department.

Follow-up on the review and approval process to expedite document review and approvals when necessary. Work within the policies and regulations as required by the company, regulatory agencies and under the Occupational Health and Safety Act.

QUALIFICATION Bachelor’s degree in Applied Science or Engineering. Minimum 5 years of experience in Pharma Manufacturing field.

High level of knowledge of cGMP; must understand how to process changes within manufacturing and have the technical knowledge in how to draft, revise, create and approve quality documents in the manufacturing area.

  • Experience in Trackwise or SAP is a plus. Experience in regulatory inspections. Excellent Technical Writing skills. Excellent interpersonal and leadership / teamwork abilities are required;
  • working in a team of 30 people but also interacting with various departments on-site. Knowledge and experience with Quality Systems software, including change control and documentation management systems;
  • experience within a Document Management System / Change Control Quality system. Excellent communication skills for working with a broad spectrum of professional and technical staff and to effectively manage the Change Control requests in an efficient and practical manner.

    BENEFITS Upon successful completion of probation, you will also be enrolled in our benefit programs Life Insurance. Accidental Death.

    Long Term Disability. Dental and Healthcare. Resolute Workforce Solution welcomes and encourages applications from people with disabilities.

    Accommodations are available on request for candidates taking part in all aspects of the selection process.

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