This role is responsible for owning and managing change controls critical to site development and managing the operational documentation updates as required by each project
Job Summary
This role is responsible for owning and managing change controls critical to site development and managing the operational documentation updates as required by each project.
Primary responsibilities include developing/updating and maintaining Operations procedures, serving as a document owner, and liaising with Manufacturing/Inspection/Engineering regarding documentation changes.
The role involves supporting data verification, reducing document turnaround times, and ensuring deviations are triaged within the established timeframe.
Matching Summary
This role is responsible for owning and managing change controls critical to site development and managing the operational documentation updates as required by each project.
Skills & Requirements
Must-have
Own and manage change controls
Update operational documentation
Develop/Update Operations procedures
Liaise with Quality Assurance
GMP standards maintenance
Technical writing for GMP documentation
Nice-to-have
Assist in generation of training materials
Support continuous process improvement
Troubleshooting investigations support
Flexible working hours may be required
Key Requirements
Bachelor’s degree in Science or Engineering
3+ years of experience in biotech/pharma
Experience with regulatory compliance in cGMP manufacturing