C&Q Document Preparation Support (Finished 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 finished drug product manufacturing systems and engineering projects. The role involves authoring protocols, reports, and compliance materials while partnering with cross-functional teams to ensure documentation meets GMP standards and regulatory requirements. Experience with packaging systems, validation lifecycle approaches, and technical writing 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 lifecycle validation approaches
- Understanding of GMP documentation practices and data integrity requirements
- Strong written and verbal communication skills
- Experience with packaging equipment and finished drug product systems preferred
What you'll be doing
- Prepare and revise commissioning and qualification lifecycle documentation for engineering projects
- Author qualification protocols, reports, risk assessments, traceability matrices, and test scripts
- Coordinate technical review cycles and incorporate stakeholder feedback into final documents
- Partner with cross-functional teams to gather technical information and ensure documentation compliance
- Track deliverables and support project execution against schedules and milestones
Privacy & handoff
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