Job Overview
- Prepare and manage validation protocols, reports, and study documentation, monitor validation progress through completion.
- Identify, document, and investigate deviations; prepare investigation reports and coordinate root cause analysis with manufacturing plants.
- Initiate and track corrective and preventive actions (CAPA) against investigations; monitor implementation and ensure timely closure.
- Prepare manufacturing process batch cards and cleaning batch cards (product changeover, periodic, and general cleaning) based on R&D and pilot reports.
- Initiate and manage change controls for manufacturing processes and product changeover cleaning batch cards through the tracking system.
- Coordinate with plants, dispatch, batch card preparation teams, and engineering departments to ensure smooth implementation of CAPA and batch card updates.
- Monitor and follow up on batch cards, cleaning protocols, and deviation closure to ensure on-time completion and compliance.
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