Rakesh K S Email and Phone Number

Providing analytical support for Generic formulation QC(OSD) RM/IP/FP/Stability Study products as per USFDA, MHRA and ICH guidelines. Hands on experience of HPLC, HS-GC, DT and Dissolution apparatus. Software knowledge on chromeleon 7.2 , Empower, Labware lims and DMS.Knowledge on documentation, stability studies, Instrument trouble shooting, handling of incidents trackwise, OOS, OOT and deviations.actively particition in regulatory audits, external and Internal audits of… Show more Providing analytical support for Generic formulation QC(OSD) RM/IP/FP/Stability Study products as per USFDA, MHRA and ICH guidelines. Hands on experience of HPLC, HS-GC, DT and Dissolution apparatus. Software knowledge on chromeleon 7.2 , Empower, Labware lims and DMS.Knowledge on documentation, stability studies, Instrument trouble shooting, handling of incidents trackwise, OOS, OOT and deviations.actively particition in regulatory audits, external and Internal audits of quality control.Responsible for calibration of Instruments HPLC, Dissolution tester and basic analytical instruments. Responsible for procurement and management standards, impurities, columns and instrument spares for existing and New projects by SAP. Show less

Providing technical and analytical support for product and product development projects.performed testing on raw materials to finished products using In-house method and ISO-17025:2017 accredited methods. Ensure that calibration of analytical instruments, the use of certified reference standards and maintenance of the equipment established (IQ,OQ and PQ)Competent in handling CFA(continues flow analyser), Karl Fischer titrator, UV Spectrophotometer, FTIR Spectrometer… Show more Providing technical and analytical support for product and product development projects.performed testing on raw materials to finished products using In-house method and ISO-17025:2017 accredited methods. Ensure that calibration of analytical instruments, the use of certified reference standards and maintenance of the equipment established (IQ,OQ and PQ)Competent in handling CFA(continues flow analyser), Karl Fischer titrator, UV Spectrophotometer, FTIR Spectrometer, Refractometer, Density meter, GC and Viscometer. Software knowledge on open lab CDS, Chemstation, flow access V3.Maintenance of documents, Chemical Inventory, instrument spares and SOP's as per the ISO-17025 requirements.Faced NABL, Internal and QMS audits. Show less