CSV Specialist
Dr Reddys laboratories
مجموع سنوات الخبرة :11 years, 11 أشهر
Involved in developing, and reviewing Computer System Validation deliverables in compliance with FDA 21CFR Part11, Gamp 5, EU Annex 11 and GMP, GLP Compliance Regulations.
Involved with System Risk and GAP Analysis.
Involved with GxP Assessment for control systems.
Directly work with QA for implementing new and upgrading previously validated systems.
Handling of the QMS documents (Deviation, change control document, CAPA).
Preparation and review of IT department SOP’s required for operation
Responsible and monitoring the Periodic Review of the Computer system.
Responsible and Review the Computer system Inventory.
Responsible to prepare the Script and participate in Execution of URS, SVP, Risk Assessment, FRS, DQ, IQ, OQ, RTM, SVR and Data migration.
Involving validation activity of Laboratories control systems like Empower, ELN, Amino acid analyser, GCMS, RIMS and LSSRM
Successful completion of Emersion DeltaV upgradation version from V13.3.1 to V 14.3.1.
Involved in developing, and reviewing Computer System Validation deliverables in compliance with FDA 21CFR Part11, Gamp 5, EU Annex 11 and GMP, GLP Compliance Regulations.
Involved with System Risk Analysis.
Involved GxP Assessment for control systems like BMS/EMS, Lyophilizer (LSI and TOFFLON) and water plants.
Directly work with QA for implementing new and upgrading previously validated systems.
Followed SOPs for data backup and Restoration procedures.
Handling of the QMS documents (Deviation, change control document, CAPA).
Preparation and review of engineering department SOP’s required for operation
Responsible to prepare the Script and participate in Execution of URS, Risk Assessment, FRS, DQ, IQ, OQ, RTM and Data migration.
Responsible to perform Qualification, Re-Qualification and Periodic Review in Water plant, AHU and PLC / SCADA, DCS (Distributed Control Systems such as Emerson DeltaV and ABB).
Involved the project of Emerson DeltaV Virtualisation system batch report generation, Application workstation installation and ABB compact HMI system upgradation.
Involved in developing, and reviewing Computer System Validation deliverables in compliance with FDA 21CFR Part11, Gamp 5, EU Annex 11 and GMP, GLP Compliance Regulations.
Involved with System Risk Analysis.
Involved GxP Assessment for control systems like BMS/EMS, Lyophilizer (LSI and TOFFLON) and water plants.
Directly work with QA for implementing new and upgrading previously validated systems.
Followed SOPs for data backup and Restoration procedures.
Handling of the QMS documents (Deviation, change control document, CAPA).
Preparation and review of engineering department SOP’s required for operation
Responsible to prepare the Script and participate in Execution of URS, Risk Assessment, FRS, DQ, IQ, OQ, RTM and Data migration.
Responsible to perform Qualification, Re-Qualification and Periodic Review in Water plant, AHU and PLC / SCADA, DCS (Distributed Control Systems such as Emerson DeltaV and ABB).
Involved the project of Emerson DeltaV Virtualisation system batch report generation, Application workstation installation and ABB compact HMI system upgradation.
Involved in developing, and reviewing Computer System Validation deliverables in compliance with FDA 21CFR Part11, Gamp 5, EU Annex 11 and GMP, GLP Compliance Regulations.
Handling of the QMS documents (Deviation, change control document, CAPA).
Involved with System Risk Analysis.
Involved GxP Assessment for control systems.
Directly work with QA for implementing new and upgrading previously validated systems.
Preparation and review of engineering department SOP’s required for operation
Responsible to prepare the Script and participate in Execution of URS, Risk Assessment, FRS, DQ, IQ, OQ, RTM and Data migration.
Responsible to perform Qualification and Re-Qualification in Water plant, AHU and PLC / SCADA, vial and ampoule line (filling, washing and tunnel).
Planning required up gradation for instruments to achieve production quality and cost minimizing.
Review of P&I, specifications, instrument data sheets
Installation, Commissioning, Calibration and Maintenance of various field instruments like pressure gauge, RTD, Weighing Load Cell etc.
Managing and Supervision of Field Instruments Installation
Involved in developing, and reviewing Computer System Validation deliverables in compliance with FDA 21CFR Part11, Gamp 5, EU Annex 11 and GMP, GLP Compliance Regulations.
Handling of the QMS documents (Deviation, change control document, CAPA).
Involved with System Risk Analysis.
Involved GxP Assessment for control systems.
Directly work with QA for implementing new and upgrading previously validated systems.
Preparation and review of engineering department SOP’s required for operation
Responsible to prepare the Script and participate in Execution of URS, Risk Assessment, FRS, DQ, IQ, OQ, RTM and Data migration.
Responsible to perform Qualification and Re-Qualification in Water plant, AHU and PLC / SCADA, vial and ampoule line (filling, washing and tunnel).
Planning required up gradation for instruments to achieve production quality and cost minimizing.
Review of P&I, specifications, instrument data sheets
Installation, Commissioning, Calibration and Maintenance of various field instruments like pressure gauge, RTD, Weighing Load Cell etc.
Managing and Supervision of Field Instruments Installation
Involved in developing, and reviewing Computer System Validation deliverables in compliance with GMP, GLP Compliance Regulations.
Involved with System Risk Analysis.
Involved GxP Assessment for control systems.
Directly work with QA for implementing new and upgrading previously validated systems.
Troubleshoot the problems and providing the best possible solution.
Hands-on experience with boards, components, and lab equipment.
Perform various duties as assigned.
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