Mohan Yadav
Kolkata
Overview
14
14
years of professional experience
Work History
Senior Executive
Sun Pharmaceutical Industries Ltd
06.2021 - Current
- Investigation of OOS, OOT, OOE, Incident to determine the underlying reason of failure
- Mitigation of impact and risk of failure
- Implementation of appropriate CAPA to improve the quality management system
- Internal audit of QC and participate in the continuous improvement activities of quality system
- Drafting of Investigation report along with risk assessment
- Write the response to corporate auditor and implementation of proposed CAPA
Senior Executive Quality Control
Fresenius Kabi Oncology
06.2017 - 06.2021
- Investigation of OOS, OOT,OOE, laboratory incidents and deviation
- CAPA management
- Track wise system
- Determine of root cause by applying appropriate tool like5-Why, Fishbone diagram, Brainstorming, FMEA, Process flow chart etc
- Improvement of Quality Management System
- Presentation of Quality metrix index
- Implementation of Global SOP
- Conducting the impact assessment and risk assessment
- Keep lab and quality system in anytime readiness mode
- Handle the non compliance and escalation of non compliance
- Monthly internal audit and response to audit
- Trending the human error and implementation of appropriate action to control the human error
- Improvement program of quality system by implementing the action proposed by Lachman consultant
- Enrichment of report drafting with engagement of Lachman consultant and USA based remediation officers
Executive Quality Control
Zydus Hospira Oncology Pvt. Ltd.
03.2015 - 06.2017
- Expertise in Chromatography
- Review of chromatogram and calculation of impurities
- Investigation of OOS,OOT and SST failure related to chromatography
- Preparation of PPT for Investigations for re-measurement and retest of OOS and OOT
- Calibration of HPLC, UV Spectrophotometer, TOC, IR,pH meter..
Officer
Torrent pharma
09.2014 - 03.2015
- Analysis of Finished products .Chromatography and data review,Preparation of Working standard ,Routing and non routing calibration of instruments like HPLC,UV,DISSOLUTION APPARATUS,DT,pH meter,Balance,Preliminary investigation of SST failure,Investigation of oos and pot
Officer
Alkem Laboratories Limited
02.2012 - 09.2014
- Analysis of Raw materials,in process sample ,finished products and stability samples.Preparation and standardization of volumetric solution.Chromatography and chrimatogram processing .Use of SAP
- Analysis of WFI,DM,RO,RAW AND other water sample.Preparation of SOP,STP,and calibration of HPLC,IR,UV,TOC ...
Managment staff
Ahlcon Parenteral India Ltd
08.2010 - 01.2012
- Analysis of Raw material, inprocess,and finished products.Preparation and standardization of volumetric solution.Water analysis.Handling of HPLC,UV,KF,AUTOTITRATOR,POLARIMRTER,LPC,IR,ANALYTICAL BALANCE,pH METER
Education
B.Pharma - Jalpaiguri
Institute of Pharmacy
01.2010
Timeline
Senior Executive
Sun Pharmaceutical Industries Ltd
06.2021 - Current
Senior Executive Quality Control
Fresenius Kabi Oncology
06.2017 - 06.2021
Executive Quality Control
Zydus Hospira Oncology Pvt. Ltd.
03.2015 - 06.2017
Officer
Torrent pharma
09.2014 - 03.2015
Officer
Alkem Laboratories Limited
02.2012 - 09.2014
Managment staff
Ahlcon Parenteral India Ltd
08.2010 - 01.2012
B.Pharma - Jalpaiguri
Institute of Pharmacy