Quality Assurance Specialist - 15-months FTC

Roche

Scotland

Remote

GBP 55,000 - 75,000

Full time

4 days ago
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Job summary

Roche in Central Scotland is seeking two Senior Quality Partners to join the OPSQ Product Partnering Team on fixed-term contracts from January 2027 to March 2028, covering maternity leave, and supporting assay production quality across operations.

You will ensure compliance with regulatory standards, oversee documentation, non-conformances, change and deviation management, and contribute to audits and continuous quality improvements.

Qualifications

  • Expert knowledge of quality management systems.
  • Ability to work with multiple teams and drive improvements.
  • Strong communication and stakeholder management skills.
  • Ability to work independently and in a team.

Responsibilities

  • Be a champion for quality across operations and drive product quality improvements.
  • Ensure regulatory compliance and proper documentation of activities and records.
  • Support non-conformance, deviation and change management processes.
  • Assist audits and maintain audit readiness and quality compliance culture.
  • Collaborate with cross-functional teams to optimize quality and efficiency.

Skills

Quality management
Regulatory compliance
Documentation control
Audits & CAPA

Job description

Quality Assurance Specialist - 15-months FTC### Quality Assurance Specialist - 15-months FTCCandidatar-se: Motherwell: Bathgate: Tempo integral: Publicado hoje: Data de término: 15 de novembro de 2026 (12 dias restantes para se candidatar): 202610-127789Na Roche, você pode-se apresentar como você mesmo, abraçado pelas qualidades únicas que traz. Nossa cultura incentiva a expressão pessoal, o diálogo aberto e as conexões genuínas, onde você é valorizado e respeitado por quem você é, e permitindo que você prospere tanto pessoal como profissionalmente. É assim que pretendemos prevenir, deter e curar doenças e garantir que todos tenham acesso aos cuidados de saúde hoje e nas gerações futuras. Junte-se à Roche, onde cada voz é importante.### A posiçãoWe are currently looking for 2 highly motivated and committed **Senior Quality Partners** within our **Operations Quality Assurance (OPSQ) Product Partnering Team** at **Roche** in Central Scotland. These fixed term contract roles will run from January 2027 to March 2028 covering maternity leave positions. Our team provides quality support and expertise across a wide range of operations departments focussing on assay production.As a Senior 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. **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: * + **Operations quality support:** Advise operations partners in quality aspects relating to manufacture and quality control including supply chain and supplier related quality topics + **Documents**: Support business partners, review and approve documents, templates and records to ensure product quality and compliance + **Non conformance management**: Support business partners, 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 + **Quality Compliance:** Proactively work with business partners to ensure audit readiness and a quality compliance culture* Support special projects or initiatives in the area of Quality* Optimize processes in order to increase quality and efficiency standards We are looking for skilled and proactive Quality Professionals to join our team. In this role, you will support various quality activities, ensuring compliance with regulatory standards and implementing continuous improvements. You will proactively 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 expert knowledge of quality management. You thrive in dynamic environments and are results focussed 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.
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