Raw Material Quality Control
Resume:
Konarak M. Taraporwala
**,******** **, ******* **** NJ-08824
***********@*****.***
Status: Citizen
Objective:
To obtain a position which will utilize my skills and experiences of 16 years, which help me advance my career in future.
Attentive and analytical pharmaceutical candidate with hands-on experience working with specialty laboratory equipment and technical procedures. Solid understanding of pharmacy practices, guidelines, industry sponsored research procedures, and Good Laboratory Practices. Known for strong organization, problem solving, and time management skills, working closely with others to create a team environment. Technically proficient in Microsoft Word, Excel and PowerPoint.
Experiences:
Position: Senior chemist
Lupin Somerset (Somerset NJ) June-2016 to Present
Responsible to perform analysis of Raw material, finished product and stability testing in DEA regulated environment for oral, nasal and rectal dosage drugs.
Responsible for performing Method validation, Development and Transfer for raw material within Lupin site using instruments like HPLC, UPLC, GC.
Take initiative to notify management and QA about any deviation or incidents occurred during analysis and responsible for preparing draft report for corresponding investigation using Trackwise software.
Routing testing of Raw material with accurate planning to have timely release for production.
Routine task also includes preparing weekly work schedule for raw material group and leading the group of five with providing any support to junior chemist as needed.
Compliant with cGMP guides and SOPs. Responsible to draft method and SOPs as needed.
Performing analysis and testing on drug substances using various lab equipment like HPLC with PDA, RI, UV Detector and GC with head space, UV, FTIR, NIR, KF, Particle size analyzer, Ph meter, conductivity meter, Refractometer, Auto titrator along with the wet chemistry.
Responsible to enter analytical results after completion of analysis in SAP system for final release of batch.
Responsible for troubleshooting of instruments like, (Lab Instrument / equipment) HPLC and GC.
Proficient with Waters (Empower 3) and Shimadzu (Class VP) data processing software.
Experiences:
Position: QC Chemist II
Sun Pharma (Cranbury NJ) November-2013 to June-2016
Responsible to perform analysis of Raw material, Finished product and Stability samples.
Participated in document review for Raw material, Finished Product, calibration document, Stability Document, OOT & OOS Report.
Planning for Analysis and support to Production to achieve the target.
Compliant with cGMP guidelines and SOPs
Performing analysis and testing on drug substances using various lab equipment like HPLC, GC with head space, UV, FTIR,NIR, KF, Particle size analyzer, pH meter, Conductivity meter, Refractometer, Auto titrator along with the wet chemistry.
Responsible for troubleshooting of instruments like, (Lab Instrument / equipment) HPLC and GC.
Prepared Monthly report to Head QC.
Detailed Knowledge of Empower 3 Data processing Software.
Position: QC Chemist III
Torrent Pharmaceuticals, Ahmedabad (Gujarat, India) September 2011-February 2013
Responsible to perform calibration and PM of HPLC, GC, pH meter and weighing balances.
Planning for Analysis and support to Production target.
Complaining with cGMP guides and SOPs
Performing analysis and testing on drug substances.
Responsible for troubleshooting of instruments like, (Lab Instrument / equipment) HPLC and GC.
Prepared Monthly report to Head QC.
Position: Quality Control Executive/Research Scientist
Lupin Limited, Ankleshwar. (Gujarat, India) December 2007-Auguest-2011
Responsible to perform all required analysis of finished product, Raw materials, Stability Samples, Working Standard Qualification, Cleaning Samples, Reaction monitoring and In process samples.
Operate analytical Instruments such as H.P.L.C (Shimadzu, Dinox, Waters),
Head space G.C (Perkin Elmer Clarus-500), G.C (Shimadzu), Polarimeter, F.T.I.R,
Karl Fischer, pH meter, Density meter, Refractometer, etc.
Calibration of pH Meter, FTIR, UV, GC, HSGC, KF Titrator, Polarimeter, Sieve Shaker, Balance and HPLC.
Review the documents of analysis as per requirement.
Experience working in 21 CFR part 11 Compliant lab with SAP and QCMS system and responsible for maintaining the record of all analyzed document.
Major contribution during Audit like, USFDA, EDQM, KFDA, MHRA, TGA and WHO.
Education:
Master of Science (MS) in Organic (medicinal) chemistry, India 2007
Bachelor of Science (BS) in Chemistry and Industrial Chemistry as Vocational subject, India 2005
Languages: Able to read, write and speak English, Gujarati and Hindi
References: Available upon request. Willing to relocate.
Contact this candidate