Job location: Ahmedabad Experience: 1-2 Years JOB RESPONSIBILITY • Review of URS, URS Traceability Matrix, DQ Protocol & FAT Protocol of Equipment. • Prepare GDP, IQ Protocol, OQ Protocol, Operation Manual & FDS • Taking Lead for Data Gathering form Cross Functional Team. • Review all Automation & Technical Data Related to Project. • Review Area layout & all the Equipment General Arrangement Drawing. • Review of All the MOC & Electro Mechanical Component Certificates. • Verification of Batch Repots, Digital Input-Output, Alarms-Interlocks & 21 CFR Part 11 Compliance. • Draft MOM Preparation of FAT Punch Points. • Final Report Preparation of Pre-FAT Activities. • CFAT (Client FAT) Perform in front of Domestic & International Client. • Hands in checking with:- Decibel Meter, Velocity Meter, Filler Gauge, Vernier Caliper, Spirit level, Moly Kit, Lux Meter, Measuring Tap • Should be able to understand the machine and software function to write Description. • More Preference to inspection/ Vision Pharma line person. Show more Show less

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Jr. Engineer - Documentation