Manufacturing Senior Associate
HyderabadFull-timeMid levelPosted 3 days ago
Mid-level mechanical and production role at Amgen in Hyderabad.
About the role
HOW MIGHT YOU DEFY IMAGINATION? The Manufacturing Senior Associate is responsible for the authoring, revision, coordination, and lifecycle management of Manufacturing controlled documents. This role partners closely with Manufacturing, Quality, Process Development, Engineering, Validation, and other cross-functional stakeholders to ensure procedures and documentation remain accurate, compliant, effective, and inspection-ready.
What you'll do
- Document Authoring & Lifecycle Management
- Author, revise, and maintain controlled GMP documents in collaboration with the document owner. Documents include: Standard Operating Procedures (SOPs)
- Global Document Elements (GDEs)
- Other controlled GMP documentation
- Ensure documents comply with Good Documentation Practices (GDP), cGMP requirements, site procedures, and global standards
What you need
- GMP
- SOP writing
- Technical writing
- Troubleshooting