Jignesh A. Email & Phone Number

Experienced Quality Professional of about 15 years in Quality Analytics, QA-QMS, AQA IPQA, QC-Chemical, Microbiology, Compliance, Production, Validations - Cleaning, Computer System, Process & Analytical Methods.Lean Six Sigma black belt and applied accelerated artificial intelligence certified, with International Project experience of about 3 years in two different countries. (Dubai & Srilanka)Handled several projects for e.g. 1) New Laboratory Setup, 2) Documentation structure development i.e. QMS, SOP, Protocols, Reports, Qualification docs etc. 3) Water treatment plant setup &4) Paperless SAP implementation - Quality & LIMS validation. Worked for A) Medical Devices - Auto Injectors, Vaccines, Biologicals, Sterile sites. B) Formulation-liquid and solid, antibiotics, anticancer sites.C) API sites & D) Contract Manufacturing sites. Sound Knowledge and experience of LIMS, SAP, Documentum, Track wise, Veeva Vault, JMP16 and Minitab software.Review of APQR, Batch Recall, Vendor Qualification - Communications, Audit Compliance, IR response, Market complaints - FAR response preparation, Trend Analysis. Faced several regulatory audits, performed several vendor and internal audits. Prepared and reviewed compliances reports related to regulatory audits.Worked alone as well as handled a team of maximum 25 people. (Indirect reportee handled up to 75)Skills: - Critical ThinkerActing with Ethics & IntegrityCollaborative & adapting to new approachesCommitted to ExcellenceVisionary