Manufacturing Senior Associate in Hyderabad, भारत

Amgen seeks a Manufacturing Senior Associate to manage controlled GMP documentation lifecycle, including authoring, revisions, and stakeholder coordination across manufacturing operations. The role ensures compliance with regulatory standards while supporting process improvements and operational excellence in drug substance, drug product, or final dosage form manufacturing.

Responsibilities

• Author, revise, and maintain controlled GMP documents including SOPs, protocols, forms, and work instructions
• Facilitate cross-functional document review meetings and coordinate stakeholder feedback across manufacturing sites
• Manage multiple complex document revisions simultaneously, tracking progress against timelines and commitments
• Generate performance metrics and reports on document health, compliance, and revision cycle times
• Identify and implement process improvements to enhance documentation efficiency and regulatory readiness

Requirements

• Bachelor's degree with 5–9 years of relevant experience
• GMP-regulated manufacturing environment experience
• Proficiency authoring and revising SOPs, protocols, forms, and controlled documents
• Strong technical writing and document management capabilities
• Knowledge of Good Documentation Practices and cGMP requirements
• Experience with electronic document management systems (Veeva, CDOCS, EDMS, TrackWise)
• Demonstrated ability to manage multiple priorities and influence stakeholders