BriefCase
BriefCase

Team Lead - Quality Control Job in Eisai Pharmaceuticals India Pvt. Ltd.

Team Lead - Quality Control

Eisai Pharmaceuticals India Pvt. Ltd. 4+ weeks ago
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Job Summary
  • Labware LIMS activities related to LAB support.
  • Creation of New product specifications and migration as per approved specification.
  • Updation of the product specifications as per revised specification.
  • Master data creation for Test solutions. Volumetric solutions and Inventory Module.
  • Project creations as per requirements by using project management Module.
  • Fixes - Testing, Validation and installation activity by using Labware LIMS.
  • Monitoring of (OOX) investigations generated in LIMS.
  • Monitoring of LOTS fetched from SAP.
  • immediate rectification of any master data error observed in LIMS.
  • Timely Closing of LIMS incidents.
  • Maintenance of LIMS data management and administration activities as per the requirements.
  • Verification and review of master data by using Labware LIMS.
  • Developing the new requirements in the LIMS by using development environment.
  • Resolving the issues in LIMS on day-to-day basis of regular Lab Support.
  • Instrument integration and Fixes related to any Laboratory instruments.
  • Change Control Initiation as per LIMS New module implementation.
  • Supporting to Other departments related LIMS Application process flow support.
  • Empower Interface with Labware LIMS lab support by using Labware LIMS.
  • Standalone Systems Interface with Labware LIMS (Ex.: Titrators, UV, IR, NMR, AAS, XRD, Particle Size Analyzer, Melting point and Viscometer)
  • Analytical balance interface with Labware LIMS. (Direct Instrument Interface issues)
  • Stability Management module support by using Labware LIMS.
  • Retain Sample Management Module support by using Labware LIMS.
  • ELN Module Master data creation and review mechanism.
  • ELN Module maintenance and enhancement activities. Related to Experiment creation.
  • Risk Assessment and Impact Assessment Preparation as part New modules implementation support.
  • Preparation and Execution of Qualification protocol as per New module installation requirements.
  • Preparation and Execution for Verification protocol a s part of Module enhancement
  • LIMS Investigations based on LIMS Error communication details and as per usage communication error details.
  • New modules designing support to vendor and Flow verification as part of New module implementation.
  • Crystal Reports Designing and Implementation by using LIMS Application.
Experience Required :

12 to 15 Years

Vacancy :

1 Hire

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