Raju Dr
Scientist @Darla R Life Sciences
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WORK HISTORY
Scientist @Darla R Life Sciences
New method Development and Validation according to ICH guidelines.o Engage in project planning, execution, method development, and validation of projects according to set standards such as USP general chapters, guidelines, SOPs, and protocols.o Good understanding of GLP regulations and exposure to external regulatory audits.o Interpreted and applied USP/NF guidelines to ensure method suitability, contributing to consistent regulatory compliance and audit readiness.o Calibration of equipment and instruments as per the schedule.o Analysis and reporting of new raw materials to meet statutory requirements.o Implementation and adherence to practices like cGMP and GLP in the R&D department.o Documentation related to Quality Management System, Environmental Management System, and Occupational Health & Safety Assessment (ISO 9001:2015, ISO 14001:2015, OSAS 45001:2018).o Stability testing as per R&D programming.o Preparation of Standard Testing Procedures (STPs) for raw materials, in-process samples, and finished products in compliance with regulatory standards.o Executed Technology transfer of analytical methods and specifications from R&D to QC and manufacturing units for new products and Scale-up activities.o Preparation and Review of Analytical Method Validation Protocol and Reports.
EDUCATION
Kakatiya University (University College of Pharmaceutical Sciences)
M. PHARMA
ABOUT RAJU DR
I operate at the intersection of pharmaceutical R&D and premium wellness…
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