1. Analysis and Method development of Raw materials, Intermediates, Finished APIs and Packaging material2. Knowledge of calibration and operational of laboratory equipments viz. HPLC, GC, UV/Vis. Spectrophotometer, FT-IR….etc3. Analytical method validation, cleaning validation and process validation as per cGMP guidelines.4. Work well under pressure within fast-placed environment5. Able to co-ordinate and prioritize workload to meet stringent deadlines6. Follow directions and work productivity without supervision7. Fast learner, grasp and apply new procedures, techniques quickly.8. Excellent written and verbal communication9. Analytical thinking and troubleshooting

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.

• Managing work successfully• Broad knowledge of analysis like raw materials, Intermediates, Finished API and Packaging materials• Handling sophisticated instruments like HPLC, HS-GC, UV/Vis. Spectrophotometer, FT-IR, pH meter…..etc.• Studying of difficult samples, analysis and establishing procedures for laboratory samples.• Committed to achieving professional excellence.

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.

Skills / Attributes Summary:Analysis and Method development of Raw materials, Intermediates, Finished APIs and Packaging materialKnowledge of calibration and operational of laboratory equipments viz. HPLC, GC, UV/Vis. Spectrophotometer, FT-IR….etcAnalytical method validation, cleaning validation and process validation as per cGMP guidelines.Work well under pressure within fast-placed environmentAble to co-ordinate and prioritize workload to meet stringent deadlinesFollow directions and work productivity without supervisionFast learner, grasp and apply new procedures, techniques quickly.Excellent written and verbal communicationAnalytical thinking and troubleshooting