Understands unit operations, various processes, Process and cleaning validation recommendations, equipment basic operations and prepares documentation to deliver zero exceptions
Demonstrates basic understanding of regulatory requirements related to technology transfer, cGMP & Sterility strategies and delivers zero gaps w.r.t the specified aspects
Understands and adheres to written procedures & basic GMP requirements as per written procedures (SOP).
Demonstartes ability to explain/ articulate procedures related to Batch documentation, trial/CB/EB protocols & reports
Prepares and execute sampling protocols/any other protocols related to EBs
Understands outcome of improvement programs from OE/EB recommendations etc., CAPAs etc., and ensures timely incorporation of these in the electronic BMRs
Understands and prepares batch documentation using MES/PASX/FTPC. Understand business processes with system and can prepare validation documentation
Understands and provides relevant safety requirements (check lists, instructions etc) in the documentation with respect to process
Skills Required: eBMR preparation/Execution/Review