LIMS
Hands on Experience in Labware LIMS v5 / v6 with Extensive support skill
Good understanding in overflow of data between LIMS and its integrations
Application knowledge over SQL LIMS integrated with java application
Good knowledge in all Modules of Labware LIMS, stability, inventory, storage location management, instrument interface, Lot, sample management, Report
Intensive knowledge in troubleshooting Labware application and Oracle database
Knowledge in Labware LIMS,SAP and COMET is preferred
Knowledge in SQL LIMS and Java Application
Knowledge in GxP terms, Compliance issues and Documentation
Trackwise
Must have worked in TrackWise Config, Design, support, TWC and Crystal Reports.
Must have worked in the latest TrackWise version v.9x and Analytics.
Must have Pharma project background with all the GxP knowledge.
Must have SDLC and Documentation exposure
Understanding of SDLC process Experience with Enterprise quality management software solutions
A Knowledge of Crystal Reports and understanding of Apache or IIS/ Web Services
Technical resolution of Incident/Request/Problem and change controls using BMC tool
Good written and verbal communication skills to effectively communicate with technical and business users
Veeva
• Provide L2 & L3 support to Veeva application.
• Handle Minor enhancements in Salesforce CRM
• Perform code reviews to identify basic technical and logical errors and resolve the business issues.
• Analyse and handle adhoc data request.
• Creating Apex classes, Apex Triggers, Visual Force pages in using Apex Programming based on Business requirements.
• Handle problem tickets, user queries and service requests / Handling RFC (Request for Changes)
• Provide production support for different operational as well as technical issues in Veeva
Oracle Argus
• Oracle Certified Argus technical resource with good hands-on in Argus Implementation
• Subject Matter Expertise on FDA Regulated GLP & GCP compliance systems
• Good hands-on experience in GDP, Regulatory Submissions in electronic Format as per FDA guidelines
• Good subject matter expertise in the Change, Release and Configuration Management as per the ITIL V3 and GXP compliances
• Must have prior knowledge of Argus Data models with independent capability to handle the ASM Operations of Oracle Argus
• Must have experience of handling Safety Database Implementation, Support and Migrations
• E2b reporting and E2b customization/Implementation, Requirements analysis, design, development, administration and unit testing of Various modules of Drug Safety Systems: Argus, Argus J
• Configuration and implementation of safety-related solutions to meet the identified needs
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at Envoy Ortus