Kirankumar Rajgor Email and Phone Number
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Experienced Researcher working in the pharmaceuticals R&D for ANDA & NDA. Strong research professional skilled in Drug substances, Excipients & packaging components method validation / verification, specification & method preparation, along with testing and experience to work under cGMP, Chang control, Deviations, CAPA, preparation & updating of SOPs.
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ManagerAmneal Pharmaceuticals Jan 2014 - PresentBridgewater, New Jersey, Us▪ Method evaluation, method development, and validation of analytical methods required for the testing of Drug substances, Drug Products like, Tablets, Hard Gelatin Capsules, Soft gelatin Capsules, Powder for Oral suspensions, and Excipients as per current USP monograph (Current / upcoming) / DMF method / in-house developed method using analytical technique like HPLC, UPLC, GC, IC, Particle Size determination using laser diffraction and morphology study using pXRD.▪ Optimization / Improvements of analytical methods, for its consistent performance across the life cycle and actively involved in troubleshoot the challenges associated during day-to-day analysis and scientific discussions on projects.▪ Managing team of scientists for Drug substances, Drug product, excipient, and packaging component testing for timely execution of analysis and release on time and meeting the project timeline.▪ Responsible for write and reviewing analytical methods, associated method validation protocol & reports, specifications, Change controls, LIR & CAPA, SOPs, Planned / Unplanned deviation reports, OOS & OOT investigations.▪ Actively involved in Troubleshooting the challenges associated during day-to-day analysis and scientific discussions on projects.▪ Responsible for the planning, execution and completion of analytical work need to respond USFDA Information request in defined timeline.▪ Responsible for planning and execution of method transfer with Quality control department, external CMO / CRO.▪ Effective interaction and co-ordination with cross functional team like, Formulation department, Regulatory affairs, Quality Control & Strategic supply chain department to drive the projects as per the organizational priority.▪ Ensuring timely Calibration / Maintenance of all instruments / equipment in the laboratory.▪ Quality Management System improvement by preparing specific and task oriented Standard Operating procedure for analytical instruments. -
Research Scientist-IiiAmneal Pharmaceuticals Mar 2019 - Jan 2023Bridgewater, New Jersey, Us -
Research Scientist-IiAmneal Pharmaceuticals Apr 2016 - Mar 2019Bridgewater, New Jersey, Us -
Research Scientist-IAmneal Pharmaceuticals Jan 2014 - Apr 2016Bridgewater, New Jersey, Us -
Group LeaderJubilant Organosys Ltd Jun 2006 - Dec 2013Noida, Uttar Pradesh, In -
Research OfficerGlenmark Research Certre Apr 2004 - Jun 2006
Kirankumar Rajgor Skills
Kirankumar Rajgor Education Details
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Sardar Patel University
Frequently Asked Questions about Kirankumar Rajgor
What company does Kirankumar Rajgor work for?
Kirankumar Rajgor works for Amneal Pharmaceuticals
What is Kirankumar Rajgor's role at the current company?
Kirankumar Rajgor's current role is Manager at Amneal Pharmaceuticals, NY.
What is Kirankumar Rajgor's email address?
Kirankumar Rajgor's email address is ki****@****ail.com
What schools did Kirankumar Rajgor attend?
Kirankumar Rajgor attended Sardar Patel University.
What skills is Kirankumar Rajgor known for?
Kirankumar Rajgor has skills like Anda, Technology Transfer, Validation, Sop, Glp, R&d, Formulation, Drug Delivery, Dissolution, Chromatography, Analytical Chemistry, Generic Programming.
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