Toronto, Ontario

Change Control Leader / Technical Writer ( Manufacturing / Quality / Pharma )

Req#: 9286617
 
Change Control Leader / Technical Writer
Toronto, ON
Start: 08/27/2019
End: 08/31/2020
 
Department: FDA Remediation Cost CA
Job Category: Manufacturing/Quality
 
· 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.
 
Skills and Experience:
Required Skills:
· CGMP
· DOCUMENTATION
· INSPECTIONS
· ORGANIZATIONAL SKILLS
· PROBLEM SOLVING
 
Additional Skills:
· WRITING SKILLS
· CHANGE CONTROL
· MICROSOFT OUTLOOK
· MICROSOFT POWERPOINT
· MICROSOFT WORD
· OUTLOOK
· POWERPOINT
· SAP
· SIX-SIGMA
· TRACKWISE
· TRAINING
· VISIO
· WORD
 
Minimum Degree Required: Bachelor's Degree
 

 
 

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