Narayan Patil

• As Team leader successfully handled the Compression-Tooling, Coating and Inspection sections. • Handled the yearly performance review, work allocation and monitoring of activities of staff and OEE monitoring. Training-cross training, guidance, support and decision on issues for staff.• Preparation of staff shift schedule, section planning, calibration, PPM and yearly training schedule.• Handling of Deviations, Market Complain, CAPAs & Change Controls, and Qualifications, Validation (process and cleaning), Risk assessment (FMEA), Batch record reviewer, Inter-unit reviewer and Temperature-RH distribution study.• SAP system: Handled SAP system for production activity• Preparation of study Protocols & Reports, SOPs, Proposals, Equivalencies and Rationale.• Attended FAT at vendor location against specification and DQ.• Audits faced are as USFDA, WHO, JAPAN, PEPFAR, MHRA, TGA, MCC etc.• Handling and execution of Electronic Batch Record.• Handling and execution of electronic cleaning and usage log.• Calibration and verification of Fette checkmaster.• As SME for Fette machine, product set-up and product related issues (Mono-Bilayer product). Operation and setup of Fette Machine, assembling and dissembling of turret.• Preparation and monitoring of departmental yearly training schedule, Job responsibility and competency matrix of teammates.• Training: Conducted monthly departmental training as per schedule, SOP’s, System, and other trainings for staff of section.• Quality Management Systems (QMS) through software are as Deviation, CAPA, and Change Controls. Expertise in an investigation of Deviation.