Sr IT Quality Analyst
Do you have expertise in the pharmaceutical industry, and passion for quality analysis? Would you like to apply your expertise to impact global teams in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.
Welcome to Global Technology Centre in Guadalajara, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities, it’s important to us that you bring your full self to work every day. To help you maintain your best self, here’s a sneak peek into some of the things this site provides for you…
The AstraZeneca GTC in GDL, is a vibrant, high-energy facility, fully equipped to support our business more than 500 IT professionals. We continuously improve our IT environment by innovating for competitive advantage. We are fully committed to redefine and provide support to enterprise-wide IT solution platforms, infrastructure and services.
What you’ll do
- Responsible for the application of Quality Management processes and services to assure that projects, systems, solutions and services delivered by IT and their 3rd party suppliers meet AZ internal and external regulatory requirements
- Act upon risks and issues in order to raise compliance and quality levels within IT and the business
- Collaborates with system/business process owner to complete or update the Risk Impact Determination (RID) as per the procedure to ensure an understanding of the Regulatory applicability (GxP, SOx, Data Privacy etc.), business, technical, software category, and regulatory risks.
- Review of System lifecycle deliverables including RID, specifications, protocols, reports, and the Test Closure Memo with a focus on cGMP impact, validation lifecycle requirements, and quality, and compliance requirements.
- Participate in the review and approval of changes, incidents and problems ensuring completion and update of System Lifecycle deliverables.
- Collaborates with the IT Project Manager to define the Quality Plan, processes, validation planning, and reporting processes.
- Participates in the Supplier Assessment to ensure that IT Suppliers meet AZ Regulatory requirements.
- Act as a QC point of contact for any potential internal and/or regulatory inspection
Essential for the role
- Strong communication, influencing and relationship building skills, capable of discussing technical IT terms with a non-technical business audience
- Ability to make pragmatic decisions by analysing highly complex situations, assessing risks and stabilizing strategic and tactical compliance/quality requirements
- Experience of providing regulatory support including validation of laboratory and business applications.
- Knowledge of industry good practice and standards such as ISO 9000, ISO 27002, CMMI, GAMP, GxP, ITIL, S404 Sarbanes-Oxley
- Experience of operating across business functions and geographies in large, complex and sometimes uncertain IT environments
- Strong change leadership and team working skills
Desirable for the role
- Broad IT management experience including project or service management
- Familiarity with technical concepts in infrastructure or applications
- External qualifications such as ISPE PCC CPIP and ISACA CISM
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.