Change Control Leader / Technical Writer ( Manufacturing / Quality / Pharma )
Change Control Leader / Technical Writer
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
· 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.
Skills and Experience:
· ORGANIZATIONAL SKILLS
· PROBLEM SOLVING
· WRITING SKILLS
· CHANGE CONTROL
· MICROSOFT OUTLOOK
· MICROSOFT POWERPOINT
· MICROSOFT WORD
Minimum Degree Required: Bachelor's Degree