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Quality Partner
Posted 3 hours 23 minutes ago by F. Hoffmann-La Roche Gruppe
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The PositionWe are currently looking for a highly motivated and committedQuality Partnerwithin ourOperations 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 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 travelling up to 50% time per week to our Tullibody location.
In this role, you will mainly:
Be a champion for engrained 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 to the regulatory requirements / quality management system and the proper documentation of all activities
You are the quality responsible person for:
Batch record review: Complete batch record review ensuring all processes are compliant with the device master record
Documents: Support business partners, review and approve documents, templates and records to ensure product quality and compliance
Non conformance management: Review and approve non conformances and contribute to investigations to identify solutions
Change management: Support business partners, review and approve changes to ensure product quality and compliance
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 in order 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.
Who we areA healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.
Roche is an Equal Opportunity Employer.