Ambitious Quality assurance executive with12+ years experience in manufacturing, Excellent reputation for resolving problem improving customer satisfaction, and driving overall operational improvements, consistently saving costs while increasing profits.
Overview
14
14
years of professional experience
Work History
Assistant Manager
Alembic pharmaceutical ltd
Vadodara
03.2019 - Current
Handling of most of QMS – CAPA and its effectiveness, change control, deviation, investigation, OOS (inclusive of disposition of batches and hold action), OOT, OOC, lab incident, events, risk assessment, and oversight observations.
Technical Support in Investigations, Part of Cross-Functional Team (CFT) in Investigations.
Communicating with different departments for QMS activities related to the QC Department.
Review and release of analytical data of intermediate, RM/PM, and FP products with accuracy, completeness, and FDA compliance.
Data include chromatography, electronic data, and audit trail.
Having a good knowledge of Labware LIMS and SAP.
Perform training on documentation, GMP compliance, and various SOPs.
Lead investigator on data integrity breaches in the laboratory.
Audit trail review of all instruments.
Review of all GCMS-MS and LCMS-MS validations.
Manage the interface with the quality compliance audit team to support audit, due diligence, and inspection readiness plans.
Administer internal audits, and provide support for external inspections.
Review and release of all specifications, STP, GTP, and IOCP.
Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.
Identified issues, analyzed information, and provided solutions to problems.
Jr. Executive
Pfizer Healthcare PVT Ltd.
Aurangabad
11.2016 - 02.2019
Planning and analysis of stability testing in quality control.
Sampling and packing of stability sample as per protocol.
Maintaining the stability chamber and cold chamber.
Sophisticated with following instrument like HPLC –UV Detector (Shimadzu,Dionex, Chromoleon Software), Gas Chromatograph (Shimadzu GC-2014, 2010), (Perkin Elmer), IR Spectroscopy(Perkin Elmer), SAP Handling, U.V Spectrophotometer (Perkin Elmer), Handling & Calibration of KF- Titrator (Metrohm) Instruments.
Executive
LUPIN LIMITED
Boisar
01.2012 - 05.2016
Familiar with sophisticated instruments like HPLC – UV Detector (Shimadzu, Dionex, Chromeleon Software), Gas Chromatograph (Shimadzu GC-2014, 2010), (Perkin Elmer), IR Spectroscopy (Perkin Elmer), SAP handling, UV Spectrophotometer (Perkin Elmer), and handling and calibration of KF Titrator (Metrohm) instruments.
Scientist
Alkyl Amine Chemicals Ltd
Pune
05.2011 - 01.2012
Familiar with the sophisticated Instruments like Gas Chromatograph (Chemito GC1000), (Perkin Elmer), U.V Spectrophotometer (Perkin Elmer), Review & Checking of reports, Handling & Calibration of KF- Titrator (Metrohm).
Education
Master of Science - Organic Chemistry
Nowrosjee Wadia College
Pune
06.2009
Bachelor of Science - Chemistry
Mahatma Phule College
Pimpri Pune
06.2007
Skills
Exceptional interpersonal communication
Teamwork and Collaboration
Staff training and development
Documentation skills
Effective leader
Data interpretation
Deadline oriented
Consistently meet goal
Languages
Marathi, Native
English, C1 Advanced
Hindi, C2 Proficient
Disclaimer
I do hereby declare that all the information’s, furnished above, are true to the best of my knowledge and belief.
Senior Manager- Key Accounts and Institution Busin at Himalaya Wellness CompanySenior Manager- Key Accounts and Institution Busin at Himalaya Wellness Company