Mahesh Shelke

Biography

QA Executive Company Name SUN PHARMA Dates Employed Jun 2012 – Present Employment Duration 5 yrs 4 mos Location ahemadnagar JOB RESPONSIBILITY: • Preparation/Review of Annual product review. • To ensure all operations in Production/QC/ are performed in accordance with the relevant cGMP guidelines. • Monitoring & review of scale up & technology transfer activity. • To review BMR /Analytical reports, QC data for each batch of product. • To co-ordinate all validation activities associated with production and QC i.e. process, equipment, utility, analytical method, testing equipment’s. • To prepare schedule and perform internal audits to ensure GMP compliance. Corrective Action Plan to be put in place for the observation and reports there of shall be filed. • To provide relevant cGMP and Safety training to new entrants and retraining to all qualified production/quality control staff. • To keep track of technical training schedule of Production/QC and keep detailed training file for all such activities. • To accompany external audit personnel during inspections and prepare corrective action plan in conjunction with Production/QC/ Stores and ensure implementation of corrective actions. • To handle all out of specifications results & Investigation as per SOP. • Change control and deviation processing. • Co -ordination in equipment and area Qualification. • Co-ordinate with RA team while DMF filing. • To Review all master documents BMR, Specifications, Validation Protocols and reports, SOP’s. • Review and approve of process development report, specification and test methods. • Preparation of documents, required for audit preparation for WHO, USFDA, TGA, MHRA, European FDA and several vendor audits. • To register all customer complaint and co-ordinate investigation activities with QC/Production and to prepare final report. • Working on Minitab, LIMS, ERP,IMS ,Track wise Software

Research Interest

Pharmaceutical Science