Devendra Shirsath
Summary
Result oriented and highly skilled Quality Assurance professional with over 10 years of dedicated expertise in pharmaceutical qualify assurance. proven track record in effectively managing various aspects of quality assurance. Seeking an opportunity to utilize my expertise in a dynamic organization to further enhance my quality proficiency
Overview
10
10
years of professional experience
Work History
Quality Assurance Executive
Torrent Pharmaceutical Ltd
12.2021 - Current
- Overseeing all Quality Assuarance (QA) activities,ensuring strict adherence to cGMp compliance on the daily shop floor , while supervising the team
- Managing Quality Management System (QMS) activities , including investigating deviations, customer compliant and out of specification (OOS) results, Reviewing Corrective and Preventive Actions (CAPA),ensuring timely implementation and verifying their effectiveness. Handling changing control processes and ensuring closure.
- All time Readiness for the Regulatory audit and compliance.
- Activity participated and faced various regulatory audits such as USFDA (5 times), MHR (3,times),EU,Japan,MALTA,ANVISA and different third party audits
- Closely monitoring of the newly implemented e-BMR (MES and IQMS) project and their effective execution on the shop floor.
- Involved in various validation and qualification activities including PPQ and CPV batches.
- Timely releasing the batches by reviewing batch manufacturing and packaging records to verify compliance with established procedure and standard.
- Conducting all IPQA activities with establish standard operating procedure including in process monitoring, shop floor remediation .
- Monitored various IPQA activities on the shop floor and also perform cleaning verification, line clearance, sampling activity, in process , AQL and cGMP compliance.
Quality Assurance - Sr. Executive
Alembic Pharmaceuticals Ltd
07.2018 - 11.2021
Quality Assurance - Trainee
Mylan Laboratories Ltd
04.2014 - 07.2018
Education
Master of Pharmacy -
HRPIPER
09.2013
Bachelor of Pharmacy -
RCPIPER
07.2011
Skills
- Team Leader
- Team Collaboration
- Multitasking
- Problem-solving aptitude
- Good Listener
- Hardworking
Personal Details
- Date of Birth: 12/22/1989
- Nationality: Indian
SOFTWARE
. Trackwise
. SAP
. MES
. IQMS
INTEREST
. CQA
. QMS
. Validation
. Qualification
. CSV
. IPQA
Timeline
Quality Assurance Executive
Torrent Pharmaceutical Ltd
12.2021 - Current
Quality Assurance - Sr. Executive
Alembic Pharmaceuticals Ltd
07.2018 - 11.2021
Quality Assurance - Trainee
Mylan Laboratories Ltd
04.2014 - 07.2018
Master of Pharmacy -
HRPIPER
Bachelor of Pharmacy -
RCPIPER
Similar Profiles
PUSHPALAL SHRESTHAPUSHPALAL SHRESTHA
Medical Representative at Torrent Pharmaceutical LTDMedical Representative at Torrent Pharmaceutical LTD
LOWIN PAULLOWIN PAUL
Sales Representative at Torrent pharmaceuticalSales Representative at Torrent pharmaceutical
PRIYANKA PANCHALPRIYANKA PANCHAL
Executive (QC) at Torrent Pharmaceutical LimitedExecutive (QC) at Torrent Pharmaceutical Limited