Quality Assurance Expert

Locations: Welwyn

Country: United Kingdom

Time type: Full time

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.

• You will be responsible for the operational management of all key Pharmaceutical Quality Management System (QMS) processes and supporting the Qualified Persons in fullfiling their company and legal obligations.
• You will be responsible for maximising the potential of the pharmaceutical business by ensuring external and global GxP Quality requirements are translated simply into Roche policies & procedures.
• You will need to be adaptable to change and entrepreneurial in nature in order to identify opportunities, while maintaining a laser focus on ensuring compliance; therefore playing a key role in retaining Roche UK’s Licence to Operate.
• You will utilise skills and capabilities to work exibly as part of an empowered, self-managed, multi-skilled team to ensure Foundational and Squad-prioritised work is delivered in line with Organisational principles.
• You need to be authentic and self-accountable, a creative problem solver, a critical thinker and able to cultivate collaborative relationships across the organisation.

This is a temporary position at Roche (initial 12 months)

• You will use broad and comprehensive expertise within the GxP Quality environment to lead “Foundation work” and partner with the business to solve complex quality issues that impact the Chapter and/or wider business.
• You will complete "Foundational work" with continual review of ‘how’ it is done to drive efciency and minimise resources required to do it (without compromising on necessary standards).
• You will act as a guardian for high standards of compliance, ethics and safety; putting patients at the centre of all actions by consistent business behaviour that complies with applicable laws, industry codes and Roche’s Code of Conduct.
• You will collaborate with internal and external parties to anticipate trends and impact to QMS, mitigate GxP compliance risks, address gaps and enable the resolution of unique or unprecedented issues.
• You will own your development to ensure continuous skills and capabilities growth in line with your passion and the needs of the Organisation (present and future).

• Bachelor Degree in Science
• Experience of:
  • Working in a GxP Quality Assurance role providing quality and compliance expertise in support of Unplanned and Planned Events, CAPA management, Document management, and Quality Risk Management
  • Commercial and/or Clinical Batch Record review for product release
  • Health Authority Inspections
• Desirable
  
  Experience of :
  • Customer Complaints processing and management system
  • QMS key performance indicators trend analysis and management reporting
  • Internal and Supplier Auditing

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites.

Besides…