Drashti Rahulkumar Rana

Demonstrates an in depth understanding of production and plant processes and procedures. Works with all maintenance personnel, supervisors and office staff to ensure that proper work lists, reports and schedules are maintained, and to optimize the CMMS and work order process for accuracy, compliance, and efficacy. Planning and scheduling for W/o request. Serves as a main contact for managing the CMMS. Monitor, reviews, and releases all maintenance requests for conversion to a work order. Must be able to exercise judgment in the assigning of code of equipment and work requests Maintains accuracy and validity of the asset data into the CMMS, reviews, recommends and implement CMMS and work order processes and improvements to maintain and enhance validity, accuracy, efficiency, effectiveness or reporting capability of the system.Create and prepare equipment and work order reports, performance indicator, and metrics on schedule or as request. Creates and manage complex queries. Assist with investigations for Out of Specification incidents and Environmental Monitoring excursions and ensure timely closure. Assist with addressing audit observations (internal, client, regulatory) Assemble and analyses data for monthly KPI’s pertaining to Facility work orders and quality metrics. Develop and provide documentation and training related to CMMS operation, work order process, and inventory management. Diagnose and trouble shoot problems/issues related to CMMS, data, and work order procedures and operations. Demonstrate ability to communicate, understand, and evaluate technical information with departmental owners, technicians, engineers, auditors,contractors, and business analyses. Update standard operating procedures related to CMMS, work orders and data documentation, and inventory management and control. Communicate with technical support department and software developer.

•Responsible for ensuring traceability of measurement system and the integrity of measuring equipment. •Perform and execute calibration testing as per methods, following the company policies, SOPs and GMP guidelines. •Document and Report results in accordance with GMP and GLP. •Maintain Analytical instruments and related software in accordance and related software in accordance with GMPs, and current regulatory expectations of data governance and data integrity. •Brief knowledge about the instrument calibrations such as Freezer, Bio-Freezer, Incubator, Centrifuge, PRT, Pressure Gauge, Pipette calibration, Air Flow, pH, Conductivity, Tube welder, RSM, Timer, Mass Flow Meter, Humidity sensor, CO2 meters, Nitrogen tank/Freezer, Thermo-mixer, water bath, Autoclave calibration and other lab related instruments. •Participate in the troubleshooting of instrument problems. •Brief knowledge about the document registration related to instruments.

• Review and Auditing the batch documents, laboratory test results resulting to finished products and raw materials. • Conduct and participate in self-inspection in accordance with GMP. • Review the BMR and BPR. Familiar with the inspection of production line. • Ensure that batch that release with GMP,GLP,SOPS and regulatory requirements and established safety standards. • Review documents to ensure they meet GMP and site SOP Requirements. • Review and Revise testing Procedures. • Familiar with the QMS. • Prepare COA for Raw Materials, Packaging Materials and Finished Products. • Conduct quality checks and inspections during all stages of production. • Maintain all daily, weekly and monthly departmental reports. • Maintain all quality records and assist in creation, updating and review of SOPs, forms and other documents.

• Perform all works in accordance with all established company policies, protocols and procedures, and governing regulator, GMP compliance and safety guidelines. • Maintain accurate documentation including lab reports, records of procedures, result and data analysis in accordance with Good Documentation Practices. • Provide technical support to other analysts when required. • Able to operate and calibration of laboratory instrumentation such as: Kart Fisher, Dissolution Apparatus, Viscometer, PH meter, Conductivity, Titration, Pipetting, Physical testing of Raw Material, IR instruments, HPLC standard preparation solution, Viscometer, DT tester, Centrifuge. • Identify simple technical problems related to instruments operation and solves as necessary. • Identify preventable errors prior to the start or completion of the test and report as appropriate. • Maintain Analytical instruments and related software in accordance and related software in accordance with GMPs, and current regulatory expectations of data governance and data integrity

Quality