Sandip Gavhane

To ensure calibration of different instruments and equipment used in analytical process.

To review complete laboratory control before release of the API.

To prepared and review of qualification and validation protocols and its execution.

To ensure good laboratory practices are followed in

laboratory and to ensure compliance for CGMP

and quality system.

To study the Stability of product and conform the quality as per the ICH guidelines up to shelf life of product.

To ensure that all analyst are qualified based on Analyst

qualification procedure and maintain the competency record for each analyst.

To ensure adherence to the safety practices in the laboratory by all QC staff.

To investigate and ensure all change controls, deviation, incidences, OOS, 00T, Market complaint documents are raised timely investigated and closed with proper root

cause.

To review and revise the SOP, specification, standard test

procedure and related documents as per regulatory requirements.

Monitoring of water analysis.

To plan, organize; schedule various activities and

implementing QC systems as per plant requirements and dispatch of Finish products.

To ensure the compliance of 21 CFR Part-11and archival of electronic data.

• Maintained detailed records of all QC activities, facilitating easy retrieval for audits or investigations as needed.
• Mentored junior staff members, helping them develop their skills and advance within the organization.
• Review Intermediate and Finished product analysis Data and Audit Trial , Monthly Audit Trial
• Calibration and maintenance of instrument like HPLC , GC , IR
• Daily Release intermediate and Finished product batches and planning of analysis
• Doing QMS Activity Investigation of Lab error, Incident, OOS, OOT

Analysis of In process Sample Using Instrument HPLC, GC, IR, UV, SOR, PARTICAL SIZE intermediate sample and Reaction monitoring sample,Analysis of change over cleaning sample like swab and Rinse and Release within time . Preperation of SOP , COA . Initiate and Doing part of investigation of Lab error, Incident, OOS and OOT

Handling instrument like HPLC (make - Water, Agilent), GC (Perkin Elmer), IR, UV, KF analysis of In process Sample,finished good Sample, Stability Sample and RM Sample. Management of Working Standard, Reference Standard, online Reporting On LIMS

Method validation and Transfer plant Scalap batches using instrument like HPLC, GC ,UV, IR testing 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. preparation of cleaning validation protocol analysis plan as per protocol . samplings and analysis of cleaning sample Swab, Rinse, change over cleaning sample and prepared final Report

Analysis of API and Tablet, Preperation Of stability protocol, incubation if stability sample, Review monthly pull out of, Allocate AR Number Sample and Analysis of Sample using instrument like 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, Dissolution for HPLC And UV