1.Department:Quality Control
Reviewer JD
1. Knowledge on Regulatory requirements.
2..Knowledge on Chromatography/Spectrophotometry/GXP
3. Knowledge on Review mechanism for all analytical documents (Lab qualification, URS, Equipment qualification, Calibrations, Method validation, Method Transfer, Method Equivalency, Experimental studies, Stability analysis and Regular analysis of (Vendor qualification/RM/IP/FP/STB).
4. Knowledge on (Feasibility study/AMV/AMT/Experimental study, Cleaning validation) Protocol preparations and review.
5. Review of audit trials for all equipments with respective software (Empower, Chromeleon, Lab solutions, Tiamo)
6. Knowledge on QMS (Incidents/OOS/OOT/Deviations/Change controls/CAPA).
QMS JD:
1. Technical write up skills on QMS
2. Knowledge on Chromatography/Spectrophotometry/GXP
3. Knowledge on QMS (Incidents/OOS/OOT/Deviations/Change controls/CAPA)
4. Review of Analytical data for Investigations/ Hypothesis/Experimental study/Re- analysis/Confirmatory analysis.
5. Involvement in investigations, evaluation of root cause and appropriate CAPA proposal.
6. Knowledge on Empower software.
Please share resume on Sh*************u@gr**********a.com
Ra****************l@gr**********a.com
While sending resume Please mention as "QC" in subject
Contact Number:9849040*** & 7995144***
Keyskills: Capa Empower OOS OOT QMS Root Cause Spectrophotometry Quality Control
Granules India Limited is a vertically integrated pharmaceutical company head quartered in Hyderabad.