Teva CSV Analyst - TAPI 

India, Uttar Pradesh, Greater Noida 

413224753

This position is available in our state-of-the-art R&D center in Greater Noida.

Validation of a new global ELN system for the R&D organization. It is starting from building the system and implementation in all the R&D sites. Once implemented completely, then to manage the system validation maintenance and change management of further enhancements. Support with some additional CSV activities for TAPI sites.

• Software Validation - Validation Plan definition, URS/FS/DS, Risk Assessment, Testing Plan and Scrips, Testing Execution, PQ / User Acceptance testing guidance and support, Validation Summary Report, system WI/SOP.
• Validation state maintenance. Periodic Reviews of Laboratory Applications Systems with respect to compliance to SDLC, User permissions and data integrity controls.
• Activities and Documentation of Data Integrity controls, Back-Up/Restore processes, Disaster Recovery processes and User Management processes on Laboratory Application Systems.
• Understanding system requirements, discussing business process / proposals / implementation issues / data security / data integrity / compliance to application guidelines, etc.
• Documenting the changes and new developments as per the documentation standards.
• Compliance with GxP Guidelines, Good Documentation practices & activities.

• Background in computer science or similar IT background, or a background in chemistry or related scientific field
• 2-5 years of experience working with CSV within the pharmaceutical or biotech industry.
• Expertise in Pharma Laboratory Application Systems - User Management, BackUp/Restore processes, Data Integrity Controls as per GxP Compliance.
• Experience in software validations.
• Experience with HP gALM system & understanding of SDLC structure.
• Documentation related to Quality processes such as Change Controls, CAPA, Deviations and Investigations.
• Knowledge of GAMP5 and regulatory guidelines such as 21 CFR Part 11, EU Annex 11, etc.
• OS: Windows
• Basic knowledge of LAN / WAN
• Basic knowledge of Servers / Switches / Routers
• Strong experience with Microsoft Office application
• Exposure to File Server/Network Shared Drives/Shared Multifunction Devices

TAPI IT QA & R&D Lead

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