Career Category
Manufacturing
Job Description
Job Description

HOW MIGHT YOU DEFY IMAGINATION?
At Amgen, our shared mission is to serve patients. Every team member contributes to our ability to consistently deliver high-quality medicines through excellence in operations, compliance, and continuous improvement.
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.
The individual serves as a key document management and process improvement resource, facilitating complex document revisions and authoring, coordinating stakeholder reviews, driving on-time completion of commitments, and supporting Manufacturing performance through effective documentation practices specifically in DS, DP, or FDP. In some instances may act as the overall business process owner for DS, DP,



or FDP. Hours for this role may vary based on global time zones, which could include hybrid hours, on call requirements, and adaptable working hours.

Key Responsibilities
Document Authoring & Lifecycle Management
• Author, revise, and maintain controlled GMP documents in collaboration with the document owner. Documents include:• Standard Operating Procedures (SOPs)
• Forms
• Protocols
• Reports
• Global Document Elements (GDEs)
• Work Instructions
• Training Documents
• Other controlled GMP documentation

• Ensure documents comply with Good Documentation Practices (GDP), cGMP requirements, site procedures, and global standards.
• Perform periodic reviews of controlled documents and drive completion of required updates.
• Review existing procedures for accuracy, consistency, and process alignment.
• Identify opportunities to improve document effectiveness, usability, an

📌 Manufacturing Senior Associate (Hyderabad)
🏢 AMGEN
📍 Hyderabad