Quality Control Supervisor in Pharmaceutical/Biotechnology/Chemical Field.
Overview
22
22
years of professional experience
Work History
Quality Control Supervisor KVK
Tech Inc.
, PA
11.2020 - Current
Stability managements in its totality
Manage group of eight chemists
Assist in troubleshooting of various laboratory instrumentation such a UPLC/HPLC, Dissolution Apparatus, and FTIR etc
Takes initiative and exhibits resourcefulness in problem solving; experience in working in a collaborative team environment
Displays effective communication skills, both oral and written
Knowledge in all aspects of 21 CFR 210 and 211
Strengths with root cause analysis and technical writing
Maintains confidentiality at all times and exercises solid, dependable judgment and discretion
Understanding of chemical component and safety practices required for handling chemicals used in batch processing and equipment and room cleaning
Senior Chemist/Lead Chemist
Aurobindo Pharma USA, Inc
12.2009 - 11.2020
Operation and Calibration of Latest microprocessor based instruments like, UPLC, HPLC (Waters, Shimadzu & Agilent)
Operation of UV-Vis Spectrophotometer
Peration and Calibration of Dissolution Apparatus (Venkel & Distek)
Organization, interpretation and analysis of data
Training of chemists on various instrumentations
Ey Responsibilities
Andling and Manage Projects
Conducting drug release/dissolution, assay of formulation trial batches using established in-house or USP method
Analysis of In-process samples, Stability batches and exhibit batches of Solid Oral Dosage forms by In-House Methods and Protocols
Ensure compliance with current SOPs, Safety and Environmental Regulations and GLP
Keeping &Managing Laboratory records, documentation as per GLP
C Analytical reviewer and LIMS experienced
Controlled DEA Cage Access and Handling Controlled Substance product.
Analytical Chemist/Supervisor
DPT Pharmaceuticals
05.2008 - 03.2009
Assist in troubleshooting of HPLC, ELSD, KF and pH instruments
Sample preparations and analysis of samples by HPLC, UV, and IR
Review of Analytical Notebooks and Training of chemists
Performed wet chemical techniques
Controlled DEA Cage Access and Handling Controlled Substance
Analytical Chemist
SUN Pharmaceutical
Cranbury, NJ
04.2007 - 05.2008
Coordinated, distributed, and monitored daily assignments in group consisting of more than ten analysts and technicians and helped in troubleshooting various equipment’s
Performed analysis of pharmaceuticals finished products by and in-house test methods using HPLC, UV, IR, and wet chemical techniques
Qualify In-House Standards using USP & Bp
Involved in review of test methods, protocol, templates and method transfer.
Analytical Chemist
ACTAVIS Pharmaceutical Inc
03.2001 - 04.2007
Performed analysis of raw materials, finished products, and product commercial shelf life (stability)
Qualifying In-House Standards using USP, EP, JP & BP
Experienced in method transfer
Working knowledge of analytical instrumentation, including HPLC, Ion-Exchange Chromatography, Refractive index detector, GC, UV, and IR by in-house test methods, USP monographs and other regulatory test methods
Also participated in the advance HPLC troubleshooting techniques
Follow established laboratory, regulatory, safety, and environmental procedures.
Chemist
CAS Chem. Inc
08.1999 - 03.2001
Performed analysis of pharmaceuticals finished products by and in-house test methods using HPLC, GC, UV, IR, and wet chemical techniques
Calibrated and maintained laboratory equipments
Ensured compliance with cGMP
Exceptional knowledge in HPLC analysis and ability to troubleshoot HPLC problems
Responsible for analysis of raw material, in-process samples and finished products by in-house and regulatory test methods using HPLC, GC, IR, UV, and wet chemical techniques
Calibrated and maintained laboratory instruments developed standard operating procedures and review test results
Prepared test reports and maintained test records.