Er.Trilochana .

Experience

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  Mylan

  Jul 2012 - May 2016

  Engineer

  Calibration of instruments and maintening of all instruments, weighing balances, PLC systems. Preparation of sops and protocols and reports.Qualifying the automation systems and data control systems. Reviewing Preventive maintainance of electrical equipments.Bills service entry and procurement of instruments and spare parts. Maintaining of spare parts and critical instruments.Closing of CAPA, change controls.Auditing the plant for Energy Management system and Environment Management systems. Coordinating with management in all audits.conducting External vendor audits.Inspection of electrical equipments in coordination with external agencies. Calibration and Maintenance processing in SAP. Show less

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  Dr. Reddy's Laboratories

  May 2016 - Aug 2019

  Sr.Team member

  Review of engineering documentation like DQ, IQ, OQ, PQ protocols and reports, SOPs. Qualifications of all process equipments, Instruments and automation systems. Reviewing on Requalification and maintenance of equipments, calibration of instruments.Scheduling of preventive maintainance for all equipments.Audit report reposonse to QA for All audits like regulatory, customers and internal audits. Tracking of all audit CAPA and Incidents CAPA. Tracking and closing of all change controls related to engineering.Tracking of all engineering projects.Review of all diagrams like GA., P&ID.Coordinating with management in all audits.Presenting engineering data in QRM. Complying the GMP, GEP requirements in automation systems and datalogging system Process equipments. Show less

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  Ajinomoto Bio-Pharma Services

  Aug 2019 - Sept 2022

  Senior Executive

  Engineering & Projects documentation and Complaince. Ensue to follow complaince practices to conform to changes in regulations and guidelines. Provide Quality & Compliance assurance services for the engineering & projects that are underGxP purview. Independent review of the project deliverables/change control/ deviations / investigation/ documents / IQ, OQ QUALIFICATIONS/ Operation related SOPs, Work Instructions.Providing Suggestions for continuous operational improvement.Monthly metrics like Monthly reports. Training coordination for the team.Providing guidance and support to team regarding QMS.Part of Audits and tracking of CAPA.Maintain storage of all the project records & handling of documents.Monitoring of all preventive maintenance activities & documents. Show less

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  Biocon

  Sept 2022 - now

  Deputy Manager