Professional exposure- Should have exposure to regulatory audit (MHRA/USFDA/TGA/ANVISA), preferable experience in liquid injection, Good GMP /WHO knowledge.
Good exposure on manufacturing investigation, risk assessment, SOP preparation/BMR review/change control/ deviation
Budgeting, forecasting, production planning & executing, strategies for de-bottlenecking of critical issues & major breakdowns rectification.
Planning and Execution of all the Project Works & activities related to finalization of URS/estimation/costing & reporting to management.
New product development procedure/concept
Computer knowledge Microsoft office and PLC/HMI operation & SAP