Qc Manager
Current
Apicore Llc
Job responsibility as a QC Manager.Management of the Laboratory: I as a QC Manager have to look after the calibration, Preventive maintenance, and validation targets for the QC Lab. Besides daily work allotment to QC chemist for Raw materials, In-process, Intermediates, Finished API, Packaging materials and Stability samples analysis. Handle deviations and Laboratory out of specifications with corrective and preventive action. Develop analytical methods for raw materials, Intermediates and finished API.; I have handled all sophisticated instruments like High Pressure Liquid Chromatograph (HPLC), Gas Chromatograph (GC), UV/Vis. Spectrophotometer, FT-IR, pH meter, Karl-Fisher, Analytical Balance, Melting Point apparatus, Autotitrator, Muffle Furnace, Vacuum oven, Hot air oven……..etc.; To look after the documentation related to US FDA. Maintain cGMP norms in laboratory. Preparation of Standard Operating, Calibrating and Preventive maintenance procedure (SOPs) for all laboratory instruments, Quality Control and Quality Assurance related SOPs. Preparation of test and specification of Raw materials, Intermediates, Finished APIs and Packaging materials.Specific Experience: Analytical method validation, Cleaning validation, Process validation of Bulk Pharmaceutical Ingredients. I have a work on number of products like, Granisetron HCl, Fomepizole, Felbamate, Molindone HCl, Procarbazine HCl, Atenolol, Warfarin Sodium, Hydroxychloroquine Sulfate, Simvastatin, Rabeprazole Sodium…..etc. Stability studies of Finished APIs as per ICH guidelines. Preparations of protocols and reports for the validations, Calibrations and Preventive maintenance. Qualification of primary reference standards and working reference standards.Technical Achievement:Approval of Technical person by Gujarat State Food and Drug Department.Participated three times US FDA and compliance without 483Participated in WHO, USFDA, European and Domestic Audits.
