CSV Analyst - TAPI

Find a Career With Purpose at Teva Keyword Location Select how often (in days) to receive an alert: CSV Analyst - TAPI Date: Jun 3, 2025 Location: Greater Noida, India, 201306 Company: Teva Pharmaceuticals Job Id: 62216 Who we are At TAPI, we re not just a company we re a community committed to advancing health from the core. As the world s leading supplier of active pharmaceutical ingredients (APIs), we partner with 80% of the top 50 global pharmaceutical companies. With a legacy spanning over 80 years and a portfolio of more than 350 products, as well as custom CDMO services, we re shaping the future of health worldwide. Our strength lies in our people a team of over 4,200 professionals across 13 state-of-the-art facilities in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. Together, we innovate, solve problems, and deliver excellence. Join us and be part of a mission that transforms lives. Location of the position This position is available in our state-of-the-art R&D center in Greater Noida. The opportunity 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. How you ll spend your day 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. Your experience, qualifications & skills 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 Make a difference with Teva Pharmaceuticals Reports To TAPI IT QA & R&D Lead