Senior Associate Manufacturing Deviation Owner Environmental and Contamination Control
Core
End-to-end management of assigned deviation records, including investigation, documentation, and resolution, ensuring compliance with site procedures and regulatory expectations.
Role type
Senior Associate Manufacturing Deviation Owner (Environmental & Contamination Control)
Builds
Deviation records, investigation workflows, CAPA plans, and data-driven conclusions for manufacturing events.
Domain
Pharmaceutical manufacturing / Environmental and Contamination Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Technical writing, Root cause analysis (RCA), CAPA development, Data integrity management, Shopfloor observations, Cross-functional coordination, Regulatory compliance, Strategic decision making, Data trending
Preferred skills
AI and digital tools application, Pharmaceutical industry experience, Science/Engineering background
Responsibilities
Define and execute investigation strategy, Conduct shopfloor observations and Gemba activities, Lead CAPA identification and development, Support CAPA and Effectiveness Verification (EV) management, Act as SME during inspections for assigned deviations, Provide inputs to deviation trending and data analysis
Seniority
Senior, hands-on IC