Sandip Gavhane

Quality control professional experienced in developing organization's quality strategy, procedures, and processes. Monitor quality performance from supply chain and throughout product development life cycle. Develop and sustain Quality Management System in accordance with ISO 9001 and other applicable standards and business requirements. Manage quality audit program to identify and resolve non-conformities and embed culture of continuous improvement.

• Analysis of raw material API & Formulation intermediate products, finished good product, calibration and maintenance of Instrument, preparation of protocol, Documentation of COA, analysis reference standard, chemical standard, analysis of API product, formulation product, stability sample analysis in stability month window, analysis of ANDA new drugs product, process validation and also raw material sampling and there analysis, water sampling and there analysis. And analysis of dissolution.
• Instruments Handling calibration and Maintenance: HPLC (water, Agilent, Shimanzhu , Thermo Venkesh), GC (Perkin Elmer),(Agilent), pH Meter (Make Lab India) K.F water content (Make Spectral Lab) Potential Meter (Make Lab India Ltd) IR (Make MB 8000) (Perkin Elmer) UV (Make Spectral Lab) (shimadzu) SOR, Classical Instrument handle: Hardness Tester, Friability tester, Disintegration tester and also analysis of LOD, Identification, TLC, set preparation of ASSAY, RS, DISOLUTIONS by UV and HPLC
• Working isn't like HPLC (make - Water, Agilent), GC (Perkin Elmer), IR, UV, KF by in process SPL, finished good SPL, Stability SPL, new drugs SPL, RM SPL. Method validation API SPL test by HPLC, GC like linearity, specificity, accuracy, precision, LOQ, LOD. Calibration and Maintenance of instrument. Wet analysis like LOD, ROI, and Harvey metal. preparation of stability protocol and incubation of SPL in diff interval. OOS, OOT investigation. Documentation of COA, Cleaning and validation of equipment sample like Swab, Rinse
• TO ANALYSE IN IP QC SAMPLE USING INSTRUMENT, HPLC, GC, IR, UV, SOR, PARTICAL SIZE. In process sample, intermediate sample and Reaction monitoring sample, Analysis of change over cleaning sample like swab and Rinse. Revie the document, chromatographic sequence, event, OOS, OOT, and Deviation Investigation Change control. Preparation of SOP, Documentation of COA
• Working on finishes good and intermediate section to analysis of finished and Intermediate samples in HPLC and GC, also work as document review, investigate Lab error, OOS, OT, Training, Change control and planning daily analysis and Release sample, to solve any difficulty in instruments and analysis Review document, online review all instruments analysis data , to handling and investigation QMS Data. Facing audit like: USFDA, MHRA, CQA, TGA, FDA, Edqm etc

9.95 per annum

• Total Experience: 10 years 2 months
• Notice Period: 2 months
• Date of Birth: 12/29/91
• Gender: Male
• Nationality: Indian
• Marital Status: Married

• To follow Lab discipline.
• To follow GLP & GMP.
• Commitment to quality & results.
• Responsibility.
• Sincere in attitude.
• Excellent problem solving skills.
• Online entry and reporting.