Teva QA Expert 

Croatia, Zagreb 

597521530

The main purpose of this role in Global IT Quality and Compliance Operations is to work on IT projects to provide guidance and support for validation and compliance of the computerized systems in the process of the System Development Lifecycle (SDLC), and to review and approve all required validation deliverables by following applicable policies, standards and procedures.

• Provide project validation support by assisting the creation and reviewing and approving all required validation deliverables from Quality perspective
• Provide system life-cycle maintenance support by creating, reviewing, approving and maintaining validation deliverables from Quality perspective
• Actively contribute to extend and preserve the Computer Systems Validation (CSV) knowledge in the Global IT Quality and Compliance Operations team and in the company
• Support the CSV continuous improvement opportunities and knowledge-sharing
• Provide local audit support
• Support global supplier qualification process
• Support procedures and guideline management
• Support training management
• Support inventory management
• Support infrastructure qualification
• Support IT Q&C process improvements

• Master’s/Bachelor’s degree
• Professional experience in CSV or SDLC activities and/or Quality Assurance (QA) or compliance activities in a regulated environment – at least 1 to 3 years
• Experience in IT system implementation
• A thorough 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
• A deep understanding of risk-based approach for validation and compliance activities
• Orientation to achieving results and attention to detail
• Excellent command of English
• Strong interpersonal and communication skills
• Excellent cooperation, analytical and presentational skills
• Proven ability as a team player in an international work environment

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