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, assisting in generation of training materials, and liaising with Manufacturing/Inspection/Engineering regarding documentation changes.
The role requires strong project management, organizational, and communication skills, with experience in regulatory compliance in cGMP manufacturing and testing of pharmaceutical products being an advantage.
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
Document ownership and management
Change control management
GMP documentation
Technical writing skills
Liaise with cross-functional teams
Nice-to-have
Continuous process improvement
Troubleshooting investigations
Flexible working hours
Key Requirements
3+ years of experience in biotech, pharma or health care
Bachelor’s degree in Science or Engineering
Experience with regulatory compliance in cGMP manufacturing