IT QA

2 weeks ago

Bengaluru, India Teva Pharmaceuticals Full time

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

How you’ll spend your day

• Provide project validation and system life-cycle maintenance support by assisting the creation, reviewing and approving of all required validation deliverables from a GxP quality perspective.
• Lead or support complex processes and new system implementations requiring a new perspective using existing solutions.
• Resolve complex validation problems using existing solutions or applying new perspectives on existing solutions.
• Actively contribute to extend and preserve the Computer Systems Validation (CSV) knowledge in the IT Q&C team and in the company.
• Provide informal guidance to internal customers and team members as well as trainings when required (e.g. in project management, usage of policies, interpretation of regulations).
• Work independently with minimal guidance.

Your experience and qualifications

• At least five years of professional experience in complex CSV or SDLC activities in a GxP environment regulated by regulations like 21 CFR Part 11 and Eudralex Annex 11.
• Validation experience with SAP ERP systems and a respective knowledge of the system’s processes.
• Knowledge of risk-based validation approach, root cause analysis methodologies as well as Data Integrity (DI) principles.
• Master’s or Bachelor’s degree

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