AstraZeneca Pharmaceuticals LP Lead-IT Quality Analyst in Chennai, India
TIDE/IT Quality Management : GCL-D3/E1
The IT Quality Management is an integral part of TIDE (Technical Innovation and Delivery Excellence) business unit within IT.
AZ IT has adopted the 3 lines of defence model and the IT Senior Quality Management Director is primarily accountable for Line 1 Quality Management. This includes;
Ensuring Compliance policies and standards are executed and adhered to across AZ IT
Ensuring Inspection Readiness for IT Systems at AZ Campuses
Day to day management of risk and controls
Promoting strong culture of compliance and risk management
Working in close partnership with operational managers/delivery managers who are responsible for implementing corrective actions and address process deficiencies
Support New Technologies within IT from the IT Quality Management standpoint
The Quality Management function is established to cover;
Project Quality Management
Service Quality Management
Regional / Campus Quality Management
This function comprises Quality Management professionals that understand AZs business processes and are experts at integrating business appropriate risk management techniques.
This function will also guide and educate business and the 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.
The Senior IT Quality Analyst will contribute to the implementation of the IT Quality Management strategy for the specific project/program that develops new solutions for the patients.
Supports ensuring regulatory compliance for the solution being developed using new technologies, especially the mobile applications/cloud platform being used in the field of medication adherence tracking.
The role will support the effective use 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
The role will act upon risks and issues in order to raise compliance and quality levels within IT and the business
Supports the roll out of training, education and awareness campaigns for quality and compliance.
Contributes to the continuous improvement of IT Polices, standards and processes
Candidate Focus & Challenge
Demonstrated ability to lead the IT Quality and Compliance input to System lifecycle activities in support of IT Delivery and maintenance, especially the development of mobile applications being used in the field of medication adherence tracking or in the related field of Software as a Medical Device space.
Collaborate closely with the project and service teams, ensuring an understanding of the areas of potential Compliance impact that the system may have based on the business process and use.
Demonstrated experience in validation and verification of Software as a Medical Device.
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 GxP applicability, 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 regulatory requirements, validation lifecycle requirements, and quality, and compliance requirements.
Participate in the Supplier Assessment.
Participate in the review and approval of changes, incidents and problems ensuring completion and update of System Lifecycle deliverables.
Ensure that relevant AZ business procedures are being adopted.
Experience in validation of Mobile Applications in the GxP space and Software as a Medical Device. Support achieving regulatory compliance for all the projects.
Collaborates with the IT Project Manager to define the Quality Plan, processes, validation planning, and reporting processes.
Ensure that the project and service teams understand the Quality processes.
Maintains expertise in validation/compliance and develops a greater understanding of quality systems.
Candidate Education, Knowledge, Skills & Experience
BE, BS in Computer or Life Sciences with about 10 years+ experience in IT Quality and/or Compliance, alternatively, 10 + years’ experience in a pharmaceutical/Medical device regulated environment or similar
Experience of operating across business functions and geographies in sometimes uncertain IT environments
Communication, influencing and relationship building skills
Understanding of change management and team working skills
Understanding of global Pharmaceutical & Medical Devices Regulations (FDA, Annex 11, Sarbanes Oxley, Quality System Regulations (Part 820) etc.)
Knowledge of industry best practice and standards such as GxP, CMMI, SPI, GAMP, ITIL, COBIT, Risk Management.
Prior experience of working with SaaS offerings such as AWS, Microsoft Azure or Google Cloud is an added advantage.
- The position will report to either the IT Quality Management Director, IT Quality Management Lead or IT Principal Quality Manager
- The ability to travel both domestically and internationally.