Revvity | About Us
Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world’s greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our diverse team of 11,000+ colleagues from around the globe are vital to our success and the reason we’re able to push boundaries in pursuit of better human health.
Find your future at Revvity.
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. This may include assistance with cyber security QMS processes for automation projects. The role is also responsible for GDPR compliance within the Oxford site.
The role will interact and work closely within the UK Quality team and will work closely with, Legal and Regulatory teams. In addition, the role will also interact with IT, Development and ODL teams on software and automation processes and systems, which impact the Company QMS and Products.
Your internal job title will be Quality Software and Data Privacy Lead.
Responsibilities
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.
Work closely with Revvity DPO for training and updates in applicable regulations for Data Privacy.
Analyze data privacy risks at the Oxford site and create/maintain change and risk management processes for Data Privacy based on applicable regulations.
Will be the first point of contact to Oxford site for any data breach or concerns from any member of staff. Responsible for escalation to DPO. Will participate in meetings and events relating to data protection including privacy case investigations.
Ensure Oxford site staff are appropriately trained in data protection.
Collaborate to develop and deploy regulatory and quality systems strategies for software 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. This includes cyber security where appropriate.
Provide quality guidance and assessment to ensure validated systems are maintained and managed in accordance with regulatory requirements.
Operate effectively across departmental and local boundaries to resolve Quality-related issues in collaboration with peer group and senior managers.
Role requirements
Education and experience
·Educated to degree level in a relevant subject or with relevant Quality and/or Data Privacy experience.
·A thorough understanding of GDPR and data protection in the UK and EU.
·Experienced in working to Quality Management principles (ISO13485 would be an advantage).
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