Technical Writer
Brainhunter Systems Ltd
North York, ON

Job Summary
One of our direct clients is looking for Technical Writer / Change control Leader at North York, ON.
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Role: Change Control Leader / Technical Writer
Location: North York, ON

Job Description:

  • 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 IO (quality, Mtech, engineering departments) and outside IO (Regulatory affairs) for evaluation of changes.
  • Ensure timely closure of change controls, including follow up on actions under other 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

Skills:

  • 5 years Manufacturing Technology / Quality Operations ideally in Pharma Manufacturing
  • 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 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.

Education:

  • Bachelor’s degree in Applied Science or Engineering, or Bachelor’s degree in relevant major with appropriate experience

Job Type: Contract

Experience:

  • Regulatory inspections: 3 years (Preferred)
  • GMP (Good Manufacturing Practice): 3 years (Required)
  • Pharma Manufacturing: 5 years (Required)
  • Change Control: 3 years (Preferred)
  • Technical Writing: 3 years (Required)