QC- QMS

• Responsible for Routine Instrument analysis of RM In-Process FG and Stability area
• Responsible for All GLP activities and day to day analysis of QC Lab
• Review of all data generate in QC viz. Analytical data calibration data stability data Instrument qualification data Investigation data
• Handling of GLP activities including the procurements of lab consumables.
• Responsible for HPLC GC IR UV and wet analysis.
• Responsible for preparation COA of Finished products Intermediate Raw material Samples and also for Standards COA.
• Responsible for analysis of stability study samples of QC.
• Responsible for Daily calibration of QC instruments (pH meter Balance Karl Fischer and other instruments) and maintain their records.
• Responsible for the prepare Qualification of the working standard Primary standard Reference standard and Impurity Standard.
• Responsible to maintain raw data sheet (Protocol) and Log Books.
• Responsible to ensure Cleanliness of Laboratory Apparatus.
• Responsible to monitor and maintain housekeeping in QC laboratory
• To Prepare SOP STP Specifications Worksheet etc.
• To investigate the failure find out the root cause and suggest the CAPA wherever required
• Candidate should have experience of handing of QMS elements viz. Lab event OOS OOT OOC Deviation CAPA and Change control
• Responsible for qualification of instruments in QC lab.

Required Skills:

Routine Instrument Analysis GLP activities QC Lab Analysis Data Review Analytical Data Calibration Data Stability Data Instrument Qualification Data Investigation Data Procurement of Lab Consumables HPLC GC IR UV Wet Analysis COA Preparation Stability Study Sample Analysis Daily Calibration pH Meter Balance Karl Fischer Qualification Preparation Working Standard Qualification Primary Standard Qualification Reference Standard Qualification Impurity Standard Qualification Raw Data Sheet Maintenance Log Book Maintenance Laboratory Apparatus Cleanliness Housekeeping SOP Preparation STP Preparation Specifications Preparation Worksheet Preparation Failure Investigation Root Cause Analysis CAPA Suggestion Handling QMS Elements Lab Event Handling OOS OOT OOC Deviation Handling Change Control Instrument Qualification