IT QA

2 months 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

• Support local sites with CSV audits.
• Support global supplier qualification process.
• Support procedures and guideline management.
• Support training management.
• Support global systems inventory management.
• Support IT Q&C process improvements.
• Support infrastructure qualification.

Your experience and qualifications

• At least five years of professional experience in CSV or SDLC activities in a GxP regulated environment.
• Experience in IT system implementation.
• In-depth knowledge of GxP compliance requirements of the European Medicines Agency (EMA) and/or US Food and Drug Administration (FDA) and other international and national GxP regulations and guidelines to validation & compliance (i.e. GAMP5, 21 CFR Part 11, Eudralex Annex 11).
• Experience with and knowledge of processes in SAP ERP systems.
• Specialized knowledge and experience in complex CSV activity.
• In-depth working experience in CSV in a regulated environment.
• Knowledge of validation methodologies and Data Integrity (DI) principles.
• A deep understanding of risk-based approach for validation and compliance activities.
• Master’s or Bachelor’s degree

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