Job requisition id 45
We are currently looking for a highly motivated and committed Quality Partner within our Operations Quality Assurance (OPSQ) Product Partnering Team at Roche in Central Scotland. Our team provides quality support and expertise across a wide range of operations departments focusing on assay production. As a Quality Partner, you will work with Operations to ensure that Roche procedures, applicable regulations, and standards (regulatory requirements of the United States Food and Drug Administration, In Vitro Diagnostics Directive of the European Union, ISO 13485, etc.) are followed during manufacturing.
This position is permanently based at our Motherwell site. However, for the first 12 months, the role will require traveling up to 50% of the time to our Tullibody location.
In this role, you will mainly:
* Be a champion for ingrained site quality supporting and enabling our business partners regarding product care and product improvement activities, as well as in all other quality aspects within the area of responsibility
* Ensure product quality and compliance with regulatory requirements / quality management system and the proper documentation of all activities
* You are the quality responsible person for:
o Batch record review: Complete batch record reviews ensuring all processes are compliant with the device master record
o Documents: Support business partners, review and approve documents, templates, and records to ensure product quality and compliance
o Non-conformance management: Review and approve non-conformances and contribute to investigations to identify solutions
o Change management: Support business partners, review and approve changes to ensure product quality and compliance
o Deviation management: Support business partners, review and approve deviations to ensure product quality and compliance
Support special projects or initiatives in the area of Quality.
Optimize processes to increase quality and efficiency standards.
We are looking for a skilled and proactive Quality Professional to join our team. In this role, you will support various quality activities, ensuring compliance with regulatory standards and implementing continuous improvements. You will collaborate with multiple teams, provide coaching and training on quality topics, and actively contribute to process innovation. Your responsibilities will include batch record review, documentation management, troubleshooting, non-conformance, change and deviation support, and supporting audits. You will have the opportunity to work independently, make impactful decisions, and drive quality improvements across the organization.
Who you are
You are a solution-driven professional with good knowledge of quality management. You thrive in dynamic environments, showing commitment in delivering day-to-day operations and long-term initiatives. With excellent communication and stakeholder relationship skills, you excel at fostering collaboration and driving results. You are able to work independently while also being an excellent team player and can make decisive decisions.