Vishwanath
QA Manager - Pharmaceutical
Banglore
Summary
Intend to work in an environment that enhances my skills and motivates me to utilize my potential to fullest extent to contribute to the company both individually as well as a team.
Working as Manager QA at BioOrganics and Applied materials Pvt Ltd Ltd from 15th Nov 2024 to till date Worked as Senior Executive at Mylan laboratories Ltd from 12th Feb 2018 to 27th Sep 2024 Worked as a Executive at Micro labs ltd (Eye Drops unit- ML14) from 02nd Feb 2017 to 06th Feb 2018 Worked with Nandu Chemicals Pvt Ltd (Active pharmaceutical ingredients) from 01st Dec 2008 to 19th Feb 2015
Overview
14
14
years of professional experience
4
4
Languages
Work History
Manager QA
BioOrganics and Applied materials Pvt Ltd
11.2024 - Current
- Making documentation of internal audit and quality assurance activities.
- Taking care of market complaints.
- Identifying the training requirement to meet the quality standards.
- Review the organization's process to ensure whether they align with the current policies.
- Develop and monitor corrective measures.
- Handling of QMS activities (Change Control, Deviations, CAPA and Incidence)
- Approvals of SOP's and COA's
- Approvals of Calibration Records
Senior Executive
Mylan laboratories Ltd
02.2018 - 09.2024
- Company Overview: A Viatris Company
- Handling of Standards, Columns, Chemicals and Laboratories reagents.
- Reviewing of QC records. (Raw data sheet and LIMS)
- Review of Working standards and In-house reference standards.
- Review of Calibration records (Analytical Weighing balance, Micro balance, High performance liquid chromatography, Ion Chromatography, Gas Chromatography, UV-spectrophotometer, Osmometer, Melting point apparatus, Micropipette, IR Spectrophotometer and Polarimeter)
- Review of Preventive Maintenance of Instruments (High performance liquid chromatography, Gas Chromatography, Karl Fischer titrators)
- Working on SAP for creation of Purchase requisition for laboratory materials and service entries for invoices.
- Handling of LIMS.
- Audit trial review of Standalone Computerized system.
- Periodic log book review.
- Handling of QMS activities (Invalid LIR, Quality impact assessment (QIA), OOS, OOT and Breakdowns).
- Supporting for CSV (Computer System Validation) activities and Instrument qualification (IQ, OQ and PQ)
- A Viatris Company
Executive
Micro labs ltd
02.2017 - 02.2018
- Company Overview: (Eye Drops unit- ML14)
- (Eye Drops unit- ML14)
Nandu Chemicals Pvt Ltd
12.2008 - 02.2015
- Company Overview: (Active pharmaceutical ingredients)
- (Active pharmaceutical ingredients)
Education
MBA - undefined
Sikkim manipal university
01.2011
B.sc - CBZ
Karnataka University
Dharwad01.2008
Pre- University - undefined
Pre-University Education Karnataka
01.2005
SSLC - undefined
CBSE
01.2003
Skills
Windows 7
Windows 8
Windows 10
MS-Office
LIMS
SAP
Trackwise
Analytical approach
Good grasping power
Enthusiastic to learn latest technologies
Good learning ability
Ability to work in team
Innovative to know new things
Activities
- Submitted the project work 'Study on Recruitment of Fresh candidates in Agastya International foundation' at Post graduation level.
- Attended Botanical garden at UAS Dharwad for project work at Graduation level.
- Attended Bird site at Magadi bird sanctuary for project work at Graduation level.
Roles And Responsibilities
Handling of Standards, Columns, Chemicals and Laboratories reagents., Reviewing of QC records (Raw data sheet and LIMS)., Review of Working standards and In-house reference standards., Review of Calibration records (Analytical Weighing balance, Micro balance, High performance liquid chromatography, Ion Chromatography, Gas Chromatography, UV-spectrophotometer, Osmometer, Melting point apparatus, Micropipette, IR Spectrophotometer and Polarimeter)., Review of Preventive Maintenance of Instruments (High performance liquid chromatography, Gas Chromatography, Karl Fischer titrators)., Working on SAP for creation of Purchase requisition for laboratory materials and service entries for invoices., Handling of LIMS., Audit trial review of Standalone Computerized system., Periodic log book review., Handling of QMS activities (Invalid LIR, Quality impact assessment (QIA), OOS, OOT and Breakdowns)., Supporting for CSV (Computer System Validation) activities and Instrument qualification (IQ, OQ and PQ)., Making documentation of internal audit and quality assurance activities., Taking care of market complaints., Identifying the training requirement to meet the quality standards., Review the organization's process to ensure whether they align with the current policies., Develop and monitor corrective measures., Handling of QMS activities (Change Control, Deviations, CAPA and Incidence)., Approvals of SOP's and COA's., Approvals of Calibration Records.
Profile
- Manager QA, BioOrganics and Applied materials Pvt Ltd, 11/15/24, Present
- Senior Executive, Mylan laboratories Ltd, 02/12/18, 09/27/24
- Executive, Micro labs ltd (Eye Drops unit- ML14), 02/02/17, 02/06/18
- Employee, Nandu Chemicals Pvt Ltd (Active pharmaceutical ingredients), 12/01/08, 02/19/15
Exposure
- FDA Audits
- MHRA Audits
- WHO Audits
Personal Information
- Date of Birth: 10/30/87
- Gender: Male
- Nationality: Indian
Disclaimer
I hereby declare that the above-mentioned information is true, as to best of my knowledge and belief.
Instruments Used
- High performance liquid chromatography (Software- Empower 3 & Chromeleon)
- Upper pressure liquid chromatography (Software-Empower 3)
- GC (Gas chromatography, software-Empower)
- FTIR spectroscopy (Software: Spectra ES)
- UV spectroscopy (Make-shimadzu, Model-UV 1700 with UV probe software)
- PH meter (Make-Mettler Toledo)
- Conductivity (Make-Mettler Toledo)
- Melting point apparatus (Make:Opti melt)
- Ion chromatography (Software: Chromeleon)
- Refractometer (Software: Anton Paar)
- Cryoscopic Osmometer (Software: Osmosoft 3000)
- Polarimeter (software: Jasco)
Timeline
Manager QA
BioOrganics and Applied materials Pvt Ltd
11.2024 - Current
Senior Executive
Mylan laboratories Ltd
02.2018 - 09.2024
Executive
Micro labs ltd
02.2017 - 02.2018
Nandu Chemicals Pvt Ltd
12.2008 - 02.2015
MBA - undefined
Sikkim manipal university
B.sc - CBZ
Karnataka University
Pre- University - undefined
Pre-University Education Karnataka
SSLC - undefined
CBSE