CSV Analyst - TAPI

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

Make a difference with Teva Pharmaceuticals