Manager, C&Q Document Preparation (Finished Drug Product / Packaging)
Amgen · Hyderabad, India
CMCFull-timeCompany career page
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Role summary
Manager leading commissioning and qualification documentation preparation for manufacturing, packaging, and facility systems at a biotechnology company. Oversees a blended team delivering GMP-compliant, inspection-ready documentation that supports engineering project execution and operational readiness across Amgen's global operations.
What they're looking for
- Bachelor's or Master's degree in engineering, life sciences, or pharmaceutical sciences
- 5–9 years of GMP commissioning, qualification, validation, or engineering experience in pharmaceutical/biotech
- Experience preparing qualification protocols, reports, risk assessments, and traceability matrices
- Proven leadership of technical teams including full-time and contingent resources
- Strong understanding of risk-based qualification methodologies and lifecycle validation approaches
- Knowledge of GMP documentation practices, data integrity, and inspection readiness principles
What you'll be doing
- Lead team responsible for C&Q documentation preparation supporting commissioning and qualification across engineering projects
- Manage work planning, prioritization, and execution for blended teams of employees and contingent resources
- Develop and oversee qualification protocols, reports, risk assessments, and related documentation using CoE standards
- Collaborate with engineering, validation, quality, manufacturing, and project teams to support qualification execution
- Monitor documentation progress, identify risks, and drive resolution of issues impacting project timelines
Privacy & handoff
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