Title:  QC Investigator

Sr. No.

Job Responsibilities

1

Have a knowledge on Quality control function like FP/RM/PM/Stability of Solid dosage forms.

2

Having a good knowledge on QC Instrumentations

3

Having sound knowledge on trouble shooting of QC instruments like Auto titrator, HPLC, GC etc.

4

Expected knowledge of 21CFR part 11 compliance and Computer system validation

5

Must having knowledge on Investigation like OOS, OOT, events and deviation management.

6

Having knowledge on LEAN management and Good presentation skill

7

Having exposure on Regulatory Audit handling and management

8

Regular review of SOPs versus practices for gap analysis.

9

Trending of QC data and deriving action plan for compliance readiness

10

Having good exposure of review of analytical raw data