Teva QA Lead Expert 

Croatia, Zagreb 

466281501

In this role in the Global IT Quality and Compliance Operations Department (IT Q&C), you will actively work on global IT projects on a senior expert level to provide guidance and support for validation and GxP compliance of computerized systems in the process of the System Development Lifecycle (SDLC). You will support the creation of all required validation deliverables and conduct their review and approval, by following applicable policies, standards, and procedures. IT projects will be primarily around SAP ERP systems with a focus on the GxP relevant areas of Procurement, Manufacturing, Plant Maintenance, Quality Management, Logistics and Master Data Management.

• 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)
• Contribute to process improvement programs in IT Q&C and solve issues by providing input and training
• Work independently with minimal guidance
• Act as a resource for colleagues with less experience
• Provides informal guidance to customers and team members when required (e.g. project management, usage of policies, interpretation of regulations)

• 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 and compliance (e.g., GAMP5, 21 CFR Part 11, Eudralex Annex 11)
• Experience with SAP ERP systems is preferred
• 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
• Knowledge of risk-based validation approach, root cause analysis methodologies as well as Data Integrity (DI) principles
• 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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