Midde Arun Kumar

Background

About Midde Arun Kumar

I am a dynamic professional with over 13 years of rich experience in Analytical Research & Development (formulations). Possess good knowledge of projects and expertise in solving technical issues. Ability to take ownership in delivering the projects within adhered timelines. Anticipating and responding to the changes on a pro-active basis. At present working as Asst manager at AET Laboratories Pvt. Ltd,[subsidiary of Alfred E. Tiefenbacher (GmbH & Co.KG)] a German based company located at Hyderabad and engaged in the development of generic dosage forms for Europe, US and rest of the world. My core duties and responsibility as follow, Analytical method development, method transfer, method verification and method validation of finished dosage forms (Parenteral and OSD) by HPLC and UPLC. Performing excipients analysis and Stability studies as per ICH. In-depth theoretical and hands-on experience in the pharmaceutical analytical method verification and validation of drug substance. Strong communication and problems solving, analytical and technical skills enable effective solutions. Full understanding of GMP compliance and good understanding of ICH and other major regulatory guidelines (USFDA, EMEA etc.). Expert in handing of HPLC, UPLC(Waters and Agilent),GC, Dissolution apparatus (Agilent & Electro lab), KF auto titrator for water content and potentiometric titration, FTIR, XRD for API characterization,DSC (thermal analysis) and Particle analyzer (PSD). Support R&D to establish new R&D analytical lab and select proper equipment for various dosage form product developments, develop SOPs and technical documents to support IQ/OQ/PQ process of equipment and documentations. Prepare technical reports and CMC sections for regulatory filings. Demonstrated ability and experience with regulatory submission writing and review (NDA and ANDA) and response of FDA deficiency letters. Project evaluation & gap analysis for global regulatory compliance. Work experience with written procedures, cGMP, quality and safety environment. Qualification and calibration of analytical instruments. Prepare and review of Lab incidents, LIR’s, OOS, OOT, Deviations, change controls investigations and providing scientific CAPAs as a technical subject matter expert. Preparation and review of STPs, Specifications, SOPs. Preparation and review of analytical method validation protocols and reports. Awareness about Data integrity requirements (21 CFR Part 210/211, Part 11) and ALCOA (+). Facing various internal and external audits.