Teva QA & Testing Professional III 

India, Karnataka, Bengaluru 

634351812

• Provide project validation support by assisting the creation, reviewing and approving of all required validation deliverables from a GxP quality perspective.
• Provide system life-cycle maintenance support by creating, reviewing, approving, and maintaining validation deliverables from a GxP quality perspective.
• Support complex processes and new system implementations requiring a new perspective using existing solutions.
• Resolve complex problems using existing solutions.
• Apply innovative system validation or implementation approaches requiring a new perspective using 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 customers and team members when required (e.g. in project management, usage of policies, interpretation of regulations).

• Degree in computer science, Information Technology or other relevant fields.
• At least two 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.
• In-Depth working experience in Computer System Validation (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.
• Strong skills in applying and guiding others through root cause analysis techniques and CAPA definition.

Ass Dir IT QA