Randstad
System Analyst
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Systems Analyst – Operational Technology
Location: Plymouth, UK (full time on site then hybrid working offered)
Contract: 2 years
Pay rate: Up to £50,000 per annum (graduates also considered)
Job Summary
The eDHR System Analyst role is responsible for delivering first- and second-line support to users of the electronic Device History Record (eDHR) system at Plymouth. Operating within the Operational Technology (OT) team and reporting to the Operational Technology Leader, the role enables users to complete system transactions effectively while ensuring compliance with regulatory requirements and quality standards.
The post-holder acts as the primary site contact for eDHR-related queries, incidents, rollout activities, and training requirements. Working in close collaboration with Quality, Manufacturing, and IT teams, they support the effective operation of the eDHR system and help maintain efficient, compliant production processes.
Change Management
- Support the implementation of change requests relating to the eDHR system, using the approved methodology.
- Ensure all changes have the appropriate level of authorisation and documentation in line with change control processes.
- Coordinate business process and system changes relating to eDHR, and organise testing or approval of changes.
- Work with Project Leaders and Change Coordinators to ensure correct implementation of eDHR-related changes.
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Stakeholder Collaboration & Reporting
- Collaborate with manufacturing, quality, and IT stakeholders to ensure eDHR system data remains relevant and fit for purpose.
- Provide business and regulatory data reports and relevant information to meet customer and site leadership needs.
- Work with Business and Functional Leaders to identify user needs within eDHR and develop strategies to address them.
- Contribute to continuous improvement initiatives relating to eDHR processes and system usage.
Education & Experience
- Experience in a regulated manufacturing environment, ideally medical devices or pharmaceuticals, or demonstrated capability.
- Working knowledge of change control processes within a regulated, high-volume manufacturing environment.
- Experience in a key functional role in Manufacturing, Quality, Supply Chain, or IT.
- Experience supporting or administering electronic record systems (eDHR, MES, ERP, or similar) is desirable.
- Project delivery and/or quality systems training or certification is desirable.
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Knowledge & Skills
- Good understanding of electronic Device History Record (eDHR) systems and their role in regulated manufacturing.
- Strong communication and interpersonal skills, with the ability to explain technical concepts clearly to non-technical users.
- Ability to diagnose and troubleshoot system and user issues methodically and effectively.
- Demonstrable experience delivering end-user training or support, either formally or informally.
- Understanding of GMP, data integrity, and regulatory requirements in a medical device manufacturing environment.
- Proficiency in MS Office applications (Word, Excel, Outlook, PowerPoint).
- Good PC knowledge and capability.
- Ability to work collaboratively with cross-functional teams and manage multiple priorities.
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