Sonia Pattanshetti

Berufserfahrung von Sonia Pattanshetti

• Bis heute 1 Jahr und 4 Monate, seit März 2023

  CSV Engineer

  WuXi Biologics Germany GmbH

• 4 Jahre und 2 Monate, Sep. 2018 - Okt. 2022

  CSV Consultant

  Medival Technologies

  • Validation Master Plans, SOP's • PLC Validation / SCADA validation • Software Validation • CSV Validation (21 CFR part 11 assessment, Risk assessment protocols and reports, URS, FRS / CS, DQ, IQ, OQ, RTM, VSR) • Facility Qualification (Clean room Validation /Heating ventilation and Air conditioning (HVAC) Validation DQ, IQ, OQ and PQ including all test) • Temperature and RH Mapping of Warehouse and Cold rooms • Process Validation (Autoclave/ CIP SIP) • Automation and PLC, SCADA Programming

• 1 Jahr und 5 Monate, Aug. 2015 - Dez. 2016

  Project manager

  Cipla Ltd

  -Data logger qualification for temperature and RH monitoring for areas as well as cold storage. -Complete installation of temperature and RH monitoring system in warehouse and qualification as well. -Protocol development, Temperature mapping, Data analysis, Cold and Hot spot, Reporting.

• 10 Monate, Sep. 2014 - Juni 2015

  CSV Executive

  Glenmark Pharmaceuticals

  -PLC and SCADA validation on Allen Bradley, Mitsubishi, Siemens, Panasonic, Schneider, B&R, etc. of new machines as well as modified machines. -Qualification and re-qualifications of machines, CSV, PLC and SCADA in the areas like Sterile, Granulation, compression, coating, packing. -Risk assessment for PLC, CSV according to ISO guidelines.

• 3 Jahre und 4 Monate, Mai 2011 - Aug. 2014

  CSV Engineer

  Emcure Pharmaceuticals

  -Responsible for QA related tasks in relation to data integrity and electronic records management -Ensure Software and IT compliance e.g. : computerized system validation, supplier -Review and approval of computerized system validation in general -Preparation of Gap analysis -21 CFR Part 210 & 211 and 21 CFR Part 11 -Quality validation (VMP, URS, DQ, IQ, OQ, PQ protocols) -GAMP 5 -Thorough and timely Deviation, CAPA, and Change Control generation -Compliance with site SOPs and regulatory guidelines

• 1 Jahr und 8 Monate, Aug. 2009 - März 2011

  Calibration Engineer

  Cipla Ltd

  • Calibration of instrument: All types of pressure gauges, Temperature gauges, Temperature controller, Temperature Indicator, Magnehelic Manometer, Timer, RTD/TC sensor, PH Meter. • In BMS calibration, pressure switches, pressure transmitter, temp transmitter, RH sensor, etc. • Preparation of room data sheet. • To assist and coordinate training activities of Engineering. • Preparation of master lists of Equipment / Instruments.