IT Quality Analyst

hace 2 meses


Guadalajara, México AstraZeneca A tiempo completo

Protecting AZs license to operate through industry leading delivery and maintenance of world class compliant innovation, projects and services.

This function comprises forward thinking IT Quality Management professionals that understand the evolving external regulatory landscape, AZs internal business processes and are experts at integrating business appropriate risk management techniques.

This function will also consult and educate the business and broader workforce on effectively integrating Compliance Requirements into all IT Lifecycle activities.

The function is truly global in scale with resources in Asia, EU, North America and South America supporting a broad stakeholder community.

Using initiative and a self-driven approach to contribute towards effective operation, the IT QA will be expected to:

- Support compliance activities throughout BAU processes and underpinning tools (e.g. Incident, Problem, Change)
- Support collaboration and adoption of the IT QMF key compliance processes globally
- Support compliance issue management processes ensuring that organisational and supplier compliance issues are identified, assessed, and resolved in support of AZ's license to operate
- Utilise the quality management planning approach and processes ensuring that organisational and supplier compliance risks are identified, assessed, and mitigated in support of AZ's license to operate
- Support Lean maturity of the internal processes owned by the QM team
- Work with Subject Matter Experts (SME’s) and peers to identify compliance activity opportunities over processes and underpinning tools to drive value and simplification
- Actively contribute towards the overall planning, governance and Tier reporting of key metrics and measures
- Support the delivery of integrated strategies for Lean, Tools, Automation, Digital and AI

Helping to protect AZs license to operate by embedding a quality and compliance culture through promotion of education and training.

The role works closely with representatives across IT functions and Business Technology Groups (BTGs), managing risks and issues to pro-actively strive to increase the levels of quality and compliance across IT.

As part of a high performing team of Global IT Quality Management professionals, the IT QA will actively engage in life-long-learning and continuous professional development, and adoption of key collaboration practices, team-work and behaviours.

**Essential Skills and Experience**
- Knowledge of providing regulatory guidance and support towards the ongoing maintenance of compliant services
- Experience in performing operational Quality & Compliance BAU support (Change Management, Incident and Problem Management, Periodic Review, Supplier Assessments)
- Knowledge and experience of working with/providing regulatory support including computerised system validation/assurance activities
- Knowledge on GxP, 21CFR part11, GAMP
- Experience of operating in large IT environments



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