Role description
This position is responsible for Quality software life cycle processes (including computer software validation) and automation following Oxford Immunotec quality management system (QMS) in relevant manufacturing and clinical laboratory facilities and in accordance with 21 CFR part 11 and where applicable IEC62304.
The role will interact and work closely with the UK Quality and Regulatory team. In addition, the role will work closely with IT, Development and ODL teams on software and automation processes and systems, which impact the Company QMS and Products.
Manage eQMS system as per applicable standards.
Effectively manages all assigned software life cycle process and automation projects through developing process, design, verification and validation strategies, and associated documentation. These will be developed against the relevant software life cycle process and automation solution requirements and procedures to ensure that compliance and project needs are achieved.
Assist in the implementation, maintenance and continuous improvement of company-wide ERP system, assisting in the Quality modules, full validation and any necessary or desired adaptations.
Collaborate to develop and deploy regulatory and quality systems strategies in compliance with all requirements, including input to research and development programs, processes and procedures that yield products that are capable of early product approval by regulators.
Collaborate to develop OI’s software development and life cycle process capabilities to support agile and commercially viable development of new technologies (including AI and machine learning algorithms), instrumentation and automation strategies.
Evaluate changes in validated computerized systems using a risk-based approach and assign appropriate levels of validation requirements.
Provide quality guidance and assessment to ensure validated systems are maintained and managed in accordance with regulatory requirements.
Responsible for the statistical data analysis of the Quality department KPI utilizing appropriate software tools, such as Power Bi, among others.
Operate effectively across departmental and local boundaries to resolve Quality-related issues in collaboration with peer group and senior managers.
Role requirements
Technical skills and abilities
Educated to degree level in a relevant subject or with relevant technical/practical experience.
Knowledge on programming, coding and use of computers with MS programs and the Internet
Experienced in working to GLP and Quality Management principles (ISO13485 would be an advantage)
Attention to detail.
Emotional skills and abilities·
Proven capability in working effectively and in applying initiative
Proactive in identifying and investigation of issues and presenting potential solutions
Able to work with minimal supervision
Able to handle multiple tasks effectively
Always working to company values.
Competence Level
Professional Level
Customer Focus
Team Work
Displaying Personal Leadership
Remembering Work is about People
What we offer
Purposeful & inclusive work environment
Dynamic culture in which customers are at the forefront
Being part of a highly qualified team that is committed to excellence
Access to cutting-edge expertise through which you can make positive impact in the world around us
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