IT Quality Analyst
Positions are open to Mexican Citizens and official residents of Mexico.
Location: Guadalajara (hybrid)
Strong English communication skills required
Must Submit Resume in English
About the AstraZeneca
AstraZeneca is a global, science-led, patient-focused pharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies. At Astra Zeneca, we’re dedicated to being a Great Place to work!
Job Description
Are you an IT Quality guide with a strong background in the pharmaceutical industry? Do you have a passion for ensuring excellence in quality standards and processes? Would you like to apply your expertise to drive impactful quality initiatives across global teams in a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you!
Accountabilities
- 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 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 Quality Point of Contact for any potential internal and/or regulatory inspection.
Requirements
- IT bachelor’s degree or IT Background: Required experience in quality process implementation, internal audits, and supplier assessments.
- Strong Interpersonal Skills: Proficient in English with excellent influencing and relationship-building skills, capable of discussing technical IT terms with a non-technical business audience.
- Decision-Making Ability: Shown capability to make pragmatic decisions by analysing sophisticated situations, assessing risks, and stabilizing strategic and tactical compliance/quality requirements.
- Project-Level Quality Planning: Conceptual and practical knowledge of quality models and standards such as ISO 9000, ISO 27002, CMMI, GAMP, GxP, ITIL, SoX (Sarbanes-Oxley), and Lean/Six Sigma.
- Software Engineering and Project Management: Understanding of software engineering and basic project management principles with a focus on metrics analysis and efficiency improvement through tools and automation.
- Cross-Functional Experience: Experience operating across business functions and geographies in large, sophisticated, and sometimes uncertain IT environments.
- Change Leadership and Partnership: Strong skills in change leadership and effective team partnership.
Desirable
- Regulatory Support Experience: Ability to provide regulatory support, including the validation of laboratory and business applications.
- IT Management Experience: Broad experience in IT management, including project and service management.
- Technical Familiarity: Familiar with technical concepts related to infrastructure and applications.
- External Qualifications: Possession of external certifications such as ISPE PCC CPIP and ISACA CISM.
