Awareness of GAMP 5 Must be familiar with computerized Analytical Software Validation etc. Must be familiar with electronic data management. Must have adequate understanding on HMI, DAS & SCADA systems from part 11 view point.
candidate who is well versed in the field of electronic data management and have a grip/an absolute understanding towards GAMP 5/ Part 11 & Annex 11 guidance for qualification and controls of QC instruments e.g. Chromeleon , other standalone computer