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 Already Working @TEVA? If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. Teva’s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws. Show more Show less
