Team Lead - Quality Control Job in Eisai Pharmaceuticals India Pvt. Ltd.
Team Lead - Quality Control
Eisai Pharmaceuticals India Pvt. Ltd.
4+ weeks ago
- Visakhapatnam, Vishakhapatnam, Andhra Pradesh
- Not Disclosed
- Full-time
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.
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