Vishal Modi Research Profile

Manager, CAL

Sunpharma Industries Ltd

Nov-2015 to Present

To review validation protocol as per approved specification and test procedure. Also review verification protocol as per pharmacopeia specification and test procedure. In case of updated pharmacopeia, need to review the protocol as per gap assessment. In all the case, protocol standard meets to ICH guideline of Analytical procedures validation (Q2R1). To review validation and verification raw data of KSM, drug substance and drug product with justified data integrity by periodic review of audit trail. Also need to confirm that Instruments, reagents, standards which are used to analysis are calibrated or validated and qualified for intend purpose of use. Also check the entries of instruments logbooks. To review validation and verification report as per in house SOP and GQS guideline. To review Method transfer raw data, protocol and report as per GQS guideline. To review cleaning validation protocol, raw data and report. Responsible for QMS document like Lab event, Repeat analysis, Investigation, CAPA, Deviation etc. Actively involve during USFDA audit at plant location and R & D centre. Review raw data for query response as per regulatory requirement. To guide analyst for correction and reporting of raw data for compliance as per quality standard and guideline.

Sr. Research Associate

IPCA Laboratory

Dec-2014 to Oct-2015

Give suggestion to synthesis team to make changes in synthesis conditions as per results obtain during reaction monitoring. Review SOPs and to look out requirement for laboratory testing like about chemicals, reagents, column, standard. Also check all available standards and reagents are not expired and can use to intend purpose. Ensure for logbook entries, proper cleaning of laboratory to avoid cross contamination.

Deputy Manager, Polymer Division

Atul Ltd

Nov-2013 to Nov-2014

Overall, In-charge of Analytical development and quality control laboratory, I was involved, To develop new methods on HPLC, GC instrument and chemical method for analysis. Methods which are developed and validated through instruments are Assay, RS, Chromatographic purity, Residual solvents etc. Also responsible for method transfer at QC department. Developed method in such way that method can be easily adopted at any sites having different make of instrument and environment. Also responsible for method validation. Give suggestion to synthesis team to make changes in synthesis root as per in process results obtain. Compilation of Method transfer protocols and reports, also conduct method transfer to QC department. Also involved in patent and literature search for new synthesis products and their analytical methods. To do Trouble shooting of various plant scale batches by HPLC, GC and Chemically. Guide QC team for testing to develop new vendor. To look out requirement for laboratory testing like about chemicals, reagents, column, Instrument AMC, troubleshooting etc. Also responsible for vendor development for chemical and instrument as per need. Provide training to R & D-analytical and QC executives for their better understanding routine work and development.

ADL Executive

Unique Pharmaceuticals Ltd, (J. B. Chemicals and Pharmaceuticals Ltd.)

Feb-2012 to Nov-2013

To do Method development and Trouble shooting of Various Analytical methods for different dosage forms by HPLC and Chemically. Conduct Stability and In-process tests for different dosage forms like Tablet, Injections and Sustain Release Drug, Cream, Gel using variety of analytical instruments for respective tests. Do qualification of standard. Compilations of stability and Method transfer protocols and reports. Do Calibrations of instruments. Trouble shooting of plant scale batches. To do verification and validation of Assay, Dissolution and RS for different dosage. Analysis of products by Chemically and instrumental, calibration of laboratory instruments like UV-Visible Spectrophotometer, Karl- Fischer, Polarimeter, FTIR, Preparation and standardization of volumetric solution.

Nature Conservation Officer

JohnsonDiversey India Professional Pvt. Ltd. (C/o Hindustan Lever Ltd.)

Sep-2003 to Apr-2005

I was involved in analysis of raw materials, finished goods by Chemical Methods (Acidity, Basicity, Active Detergency, Non-Ionics Contents, Total Fatty Acids, Total Solids, Chelating Value) and also responsible for Production Planning and production of finished goods. I have knowledge of various analytical techniques like HPLC, Auto titrator, Polarimeter, Sonicator, FTIR Spectrometer, Karl Fisher Titrator, UV Spectrophotometer, pH meter, Polarising Microscope etc. Also familiar with Chemical Analysis like acid-base, redox, complexometric, argentometric titration. I had worked with toxic and moisture sensitive chemicals like SOCl2, DCC, DMAP, POCl3, P2S5, Lawesson's reagent, Vilsmeier reagent etc. Also, familiar with chalcone, amide, ester, Schiff's base synthesis, cyclization, halogenations, diazotization, and alkylation reaction. I have knowledge of column chromatography to purify the organic compounds. Also familiar with TLC, NMR and FTIR interpretation.