Ashutosh Tiwari

• Highly motivated and result-oriented professional extensive experience of over 7.8 years in pharmaceutical industry across diverse functions like Implementation across various locations; Internal and External Audits; Training & Employee Engagement and so on.
• Strong exposure of participating in external audits of various regulatory authorities such as USFDA, TGA and MHRA
• Drove the effective implementation of cGMP and GLP based policies, systems and procedures across all the Laboratories at the site by ensuring implementation of all required SOPs in order to ensure that individual activity at each laboratory is performed in compliance to GMP and regulatory requirements
• Managed execution of QA and QC activities like transfers of analytical methods, validation analytical methods and their regulatory submissions, evaluation of pharmacopoeia method against in-house developed methods & routine release analysis in Quality Control Laboratory for formulation plant
• Comprehensive knowledge of HPLC, XRD, G.C., I.R., UV, Dissolution Tester, Disintegration Test Apparatus, Friability Test, Classical Wet Analysis and necessary documents to new entrants
• Monitored strict adherence to regulatory guidelines and Pharmacopial standards like USP, BP and EP
• Engaged in bulk analysis, process validation and hold time study, finished product analysis, physical parameter, good document practices, and good laboratory practices; examined the finished product documentation
• Comprehensive knowledge of formulation of injections, tablets, capsules, dry-powder injections, dry syrup and so on
• A forward thinking person with strong communication, analytical & organizational skills; well organized with a track record that demonstrates self-motivation & creativity to achieve corporate goals

• Shimadzu, Waters
• U.V. Spectrophotometer: Shimadzu,
 Spectra Manager
• Dissolution test apparatus (Labindia, Electrolab).
• Karl-Fischer Auto titrator. (Metrohm)
• IR Spectrophotometer-Shimadzu
• Other Instruments: Potentiometer
Auto Titrator Apparatus, Refractometer, Polarimeter, pH Meter, Viscometer, IR Moisture Balance, Analytical 

 Balances, Drying Oven, Vacuum Oven, Melting Point Apparatus, Tap Density Apparatus And Sieve Analyzer

• Analyzing quality aspects, developing new quality resources and ensuring customer satisfaction
• Formulating, implementing and monitoring stringent QA/QC management system and quality plans/manuals

to ensure high quality standards
• Directing quality control activities and implementing effective techniques to bring efficiency in operations to improve quality standards
• Identifying, calibrating and adjusting all inspection, measuring and testing equipment and devices that can affect product quality at prescribed intervals or prior to use
• quality at prescribed intervals or prior to use
• Identifying, calibrating and adjusting all inspection, measuring and testing equipment and devices that can affect product.
• Monitoring the Quality Control Department activities and ensuring timely service to all internal customers
• Inspecting Tablets and Capsules and calibrated various analytical instruments
•Performing raw material (API/Excipient) testing as well as sampling and testing of packaging components like bottles,