Milind Dagadu More

WORK HISTORY

EDUCATION

ABOUT MILIND DAGADU MORE

Experienced Quality Specialist with a demonstrated history of working in the research industry. Skilled in Pharmaceutics, Good Laboratory Practice (GLP), Validation, GMP, CSVC and Quality Assurance. Strong quality assurance professional with a Master of Science (M.Sc.) focused in Chemistry from Vinayaka Mission\'s Research Foundation - University. Computer System Validation | IT Compliance for Life Sciences | Project Management | Gap Analysis | GxP Assessment | V Module life cycle. Generating and Review of validation deliverables like Validation Plans | Test criteria | Specifications (URS, FRS, FDS)| Risk Assessments (IRA, FRA)| Qualification Protocols (IQ, OQ, IOQ, PQ)| Traceability Matrix | Summary Reports. System Administration - User Management | Policy generation and Implementation | Review of system Audit Trail 4. Review and approval of CSV related documents (LIMS, ELN, MES, QMS-Trakwise, eDMS, RFID, LMS & over all qualification activity of Laboratory equipments/ Applications, protocols, reports etc). Verification and approval of Instrument operating procedures, IQ/OQ/PQ/DQ of all applications/ systems, instrument software’s. Support to User for query related to LIMS, QMS-Trackwise, DMS, RFID, LMS etc. Handling of user management for all QC related instrument applications including Karl-fischer, HPLC, UPLC, GC (Chromeleon Application), PAMAS, LC-GC Solutions, Balance, pH Meter, ICP-MS, etc. Exposure to Change Control | Deviations | Discrepancy | Incident | CAPA management 9. Being a part of the investigations, review and approval of deviations, Laboratory incidents, CAPA. Review and approval of procedures related to computerized system. Conducting regular GMP rounds in the Quality control laboratory. Exposure to FDA’s 21 CFR Part | EU Annex 11 | GAMP 5 | other regulatory compliance and adherence.