Experience

• 

  Cipla, meditab

  Mar 2000 - Mar 2002

  Qc officer

  Started my career with this organization and was involved in analysis of tablets/capsules and API samples. This included preparation of working standards and evaluation used for routine analysis and analysis of stability samples as per the schedules.

• 

  Megafine pharmaceuticals private limited

  Mar 2002 - May 2007

  Qc executive

  In this role, I was actively participating in synthetic process set up of lab scale batches and technology transfer in commercial scale up of lab scale batches. Developed stability indicating analytical methods for reaction monitoring, and for APIs, intermediates and raw materials. Engaged in analytical method validation and for cleaning ancillaries for APIs, intermediates and raw materials including IPC (in process control). Prepared and reviewed validation protocol and performed stability studies. Involved in method development and method validation of residual solvents on GC and maintained primary reference and working reference standards. Facilitated acquisition of certification related to QMS and EMS from ISO, WHO and US FDA. Show less

• 

  Johnson & johnson

  Jun 2007 - Mar 2015

  Senior scientist/executive global analytical r&d, drug products & apis, johnson and johnson, mumbai

  Growth Path:Jun 08– Mar 15: Senior Scientist/Executive Global Analytical R&D, MumbaiJan 08– May 08: Senior R&D Officer Global Analytical R&DJun 07– Dec 07: R&D Officer Global Analytical R&DMy key responsibilities include development of rugged & stability indicating HPLC/UPLC analytical test methods for APIs & drug products in line with the FDA regulations. This involves planning and executing analytical method validations, preparing validation protocols, reviewing and approving reports, reviewing raw data of analysis & preparing other relevant reports.The role also includes performing impurity profiling, stability studies, making observations at predetermined time frames & documentation.A few process improvements:Created standard base or chassis for development of analytical test methods which can act as starting point and reduce the development life cycle time frame.Developed starting reference database containing different types of impurities present in drug products.I have facilitated transfer of analytical technology to global R&D Centers/QC Labs, managed OOS/OOT investigations & maintained cGMP practices. Engaged in HPLC/UPLC troubleshoot management, monitored reconciliation of reference & working standards, led qualification of newly procured instruments.Developed & validated stability indicating analytical methods for formulations with combination of one or more following actives - Norfloxacin, Tinidazole, Pyrantel Pamoate, Morantel Citrate, Cetirizine, Acetaminophen, Phenylephrine, Chlorpheniramine Maleate, Dextromethorphan, Meclizine, Multivitamin, Ciprofloxacin, Diphenhydramine, TiO2, Chlorphenesin,Ibuprofen etc. Show less

• 

  Johnson & johnson medtech

  Apr 2015 - now

  Assistant manager quality assurance

  More than 22 years of diversified experience in pharmaceutical, Medical Devices industries handling Drug Products, Drug Substances, Medical devices and combination products in various fields like Quality assurance, Quality Control, Analytical R & D, Synthetic R & D etc.Expertise in master data configuration management and deployment of Laboratory Information Management Software (LIMS). Well versed with Software Development Life-Cycle (SDLC) process.Responsible for ETHICON product Information Database in SAP system.Responsible for smooth functioning and software lifecycle management with 21 CFR compliance requirements.SME for Lifecycle management for Laboratory Equipment, Analytical Test Methods, Change Control Process, concurrent process validations, Retrospective validation like Product Quality Review (PQR), Non-conformance/ CAPA process etc.Moved as Senior Executive and promoted to Assistant Manager in Medical Devices ETHICON, Aurangabad from Senior Scientist, Analytical R & D of drug products/ APIs, International Technical Centre (ITC), Johnson & Johnson Limited, L.B.S. Marg, Mulund, Mumbai. Show less