Brainhunter Systems Ltd
North York, ON
One of our direct clients is looking for Technical Writer / Change control Leader at North York, ON.
Role: Change Control Leader / Technical Writer
Location: North York, ON
- 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
- 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.
- Bachelor’s degree in Applied Science or Engineering, or Bachelor’s degree in relevant major with appropriate experience
Job Type: Contract
- 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)