Suresh Shitole

Biography

 Broad knoweldge of the pharmaceutical industry , including indepth operation knoweldge of functions invlolved in analytical during drug development/commercialization. Successful track record of team leadership and project managment in research and development environment. Significant knowledge of cGMP and Regulatory requirements Experience in QMS and compliance systems including regulatory audit preparation  Knowledge of analytical method tech transfer and validation, with demonstrated track record in successful method transfer activities Track record of cross functional working  Managed activities at both internal and external testing laboratories Hands on experience leading investigations into quality incidents or deviations including root cause analysis, impact assessment, and CAPA Excellent communications (written and verbal) and influencing skills. Supervisory experience including coaching, development, and mentoring

Research Interest

 HPLC, Validation