Devangiben Patel

Operating of LIMS ,SAP, Track wise software and Minitab software for management of the QAMS (Quality Assurance Management system).Preliminary investigation of OOS and OOT as finding of root cause,CAPA and preparation of report. Investigation of OOS and OOT using the tools like 6M, Fault tree analysis, FMEA. Handling of the Laboratory Deviation and Market Complaint.Providing training of the Guidelines ICH Quality, GMP, GXP, Safety, 5s, 6 Sigma, Lean, Kaizen, Poka Yoke, 21CFR parts.

 Analysis of the in process, Stability studies, raw material and finished product samples of APIs.  Calibration and Qualification of instruments (Balance, pH meter, HPLC, Oven, Karl Fischer, Potentiometer).  In house analytical method validation of intermediates.  Operating of LIMS (Laboratory Incident Management System), TrackWise software for OOS, OOT, Deviation, Customer Complaint, Market Complaint and Laboratory incidences.

Analysis of the in process, raw material and finished product samples of APIs.Installation, qualification and calibration of the laboratory Instruments.Handling of the Internal and external audit.Handling of Process Validation (Retrospective Process Validation), Cleaning Validation and Analytical Method Validation.Handling of Vendor Qualification.

Regulatory affairs and new drug application, Modern pharmaceutical Techniques, Experimental Design and Patent. Master thesis: Development and validation of stability indicating analytical method for simultaneous estimation of Metformin Hydrochloride and Saxagliptin in bulk and its formulation.

Bachelor of Pharmacy Pharmaceutical engineering, Pharmaceutical Chemistry, Human Anatomy, Physiology and Health Education, Pharmacognosy, Pharmaceutical Microbiology & Biotechnology, Bio-Chemistry, Pharmacology, Pharmaceutical Chemistry, Pharmaceutical Management, Medicinal Chemistry.