C&Q Document Preparation Support (Drug Product)
Amgen · Hyderabad, India
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Role summary
Amgen seeks a Senior Associate to prepare and coordinate commissioning and qualification documentation for engineering projects and GMP manufacturing systems in drug product operations. The role involves authoring protocols, reports, and compliance documents while collaborating with cross-functional teams to ensure inspection-ready deliverables aligned with regulatory standards. Experience with sterile manufacturing systems, qualification activities, and GMP documentation practices is preferred.
What they're looking for
- Experience in GMP commissioning, qualification, validation, or technical operations
- Proficiency authoring C&Q lifecycle documentation including protocols and reports
- Knowledge of risk-based qualification methodologies and validation lifecycle approaches
- Understanding of GMP documentation practices and data integrity requirements
- Strong written and verbal communication with excellent organizational skills
- Experience supporting drug product manufacturing systems and sterile processing equipment
What you'll be doing
- Prepare and revise commissioning and qualification lifecycle documentation for engineering projects
- Author qualification protocols, reports, risk assessments, and traceability matrices
- Coordinate technical review cycles and incorporate revisions into final documents
- Partner with cross-functional teams to gather technical information and ensure compliance
- Track deliverables and support execution against project schedules and milestones
Privacy & handoff
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