Davander Kumar Email & Phone Number

My Key Experience: 1) I have >15 years of QA/QC experience in green and brown field organization.2) Overall Key excellence: Key activity i.e. establishment of new laboratories, PR and PO lab items, SAP, Oracle, NABL handling, MIS handling, customer complaints, RCA, CAPA, having GMP knowledge, OOS, QAP, QMR, dispatch activity, supplier validation, documentation (DDC) controlling, review BMR, ECR, STP/Spec/SOP, Product Stability, Change Control, Lab Legal Compliance, Compliance of Testing RM, PM, SFG & FG, Lab Instruments Calibration & Troubleshooting, Operating of GC, GCMS, HPLC, UPLC, FTIR, IC, Balance, pH Meter, Ion Analyzer, KF, Headspace etc.Key Role and Responsibility:1) Handling Internal and External Audit and visit of customer and IMS ISO-9001:2015, ISO-14001:2015 & ISO-45001:2018 and GMP.2) Strengthen NFASL quality department from green field activity with ~ 28 Manpower.3) Handling monthly basis Quality dept. MIS ppt prepared and explain to top management.4) Review key quality activity i.e. QC Analysis of RM, PM, FG, IPQC, BMR, ECR, SOP, STP, Specification, QAP.5) Handling of dispatch activity, SAP, Customer complaint, RCA investigation, implementation of CCA.6) Handling all quality attributes such as DDC, audit trail, data integrity, FG return and recall, Vendor Qualification.7) Tracking of change control, NC, CCA, OOS and plant round observation to identify the OFI and their closure action plan.8) Handling & calibration of Lab instrument like GC, GCMS, HPLC, UPLC, FTIR, IC, Balance, pH Meter, Ion Analyzer, KF etc.9) Analysis and sampling of RM, PM, IP, FG and Vendor sample and prepare approval or rejection test report COA, NC, monitors shift wise QC on-going activities with respect to compliance the defined SOP/STP/Spec. 10) Handling sampling of gas samples, solid powder, Granules, liquid, semisolid with safe and secure manner.11) Trend data analysis of quality report for IP/RM/PM/FG and their tracking to improvement quality.12) Handling NABL audit related document and inline to compliance ISO/IEC-17025 standard.13) Review Quality Control analytical data, release the COA and prepare NCR for NC/OOS products

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  Vinayaka Mission'S Research Foundation - University

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