Description:
1. Candidate should be aware about GMP/GEP.
2. Knowledge about documentation activities like Protocol, report, justification, equipment qualification etc.
3. Knowledge on QMS like change control, deviation, CAPA, SOP drafting, audit compliance etc.
4. Should be aware about GMP guidelines like ICH, ISO, WHO, USFDA, EDQM.
5. Should be familiar with ALCOA, ALCOA+, 5S, root cause analysis method, document upkeep, tracking mechanism.
6. Computer literacy with MS office, SAP, QMS softwares etc.
7. Department training co-ordination, logbook management etc.
