Title:  Officer - QC Micro

Qualification M. Sc. 

Department Microbiology 

Section QMS 

Areas of Responsibility Ensure the compliance in the microbiology laboratory. 

To monitor the health of Quality Management System (QMS). 

To perform the investigations pertaining to deviations (EM and laboratory), laboratory events, Out of specification (OOS), Out of Trends (OOT). 

To provide support to cross-functional team in any investigation and identification of Root Cause Analysis (RCA) and CAPA. 

To review and update the SOPs pertaining to investigations are in-line with the recent developments or observations from the regulatory perspective. 

To be part of the audit team and ensure audits are completed within the define timelines. 

To be an auditee in internal and corporate audits. 

To prepare audit response for all observations within the defined timelines. 

To track and ensure that all the proposed corrective and preventive actions (CAPA) are closed within the defined timelines. 

To track and ensure that all the change controls are closed with the defined timelines. 

Qualification M. Sc. 

Department Microbiology 

Section Sterility, BET PET and PMT 

Areas Of Responsibility Temperature and pressure recording, cleaning and sanitization log book maintenance. 

Balance and pH meter calibration. 

Execution of protocol based activities. 

Calibration of Weighing Balance and Auto Pipette. 

Bacterial Endotoxin testing of Raw material, packing material, Water Samples, In-process, Finished and Stability samples. 

Analytical method validation of Bacterial Endotoxin test. 

To perform Preservative Efficacy Test  

Performing Sterility Test of Finish Product, Stability, In process Samples. 

Performing Particulate matter test of In- Process samples, Finish Product and Stability samples by Liquid Borne Particle Count System.