Quality Systems Expert

United Kingdom, Slough

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

We are currently looking for an experienced Quality Systems Expert to be join our Centre of Excellence for biopharmaceutical process development and small-scale GMP manufacturing in Slough, UK.

The Quality Systems Expert will provide QA oversight of the Lonza Slough Pharmaceutical Quality System (PQS) whilst managing and support GMP issues through the PQS and site governance mechanisms to support Site operations and Senior QA leadership.

Key responsibilities:

  • Use knowledge of GMP and quality processes to actively identify, suggest, participate in and manage continuous improvement to ensure that PQS remains effective, efficient, simple and compliant
  • Monitor, analyze and interpret Site quality metrics and ongoing quality trends for risks and deviations to provide information to the Site.
  • Ensure actions are taken in a timely manner to address trends and when  issues are highlighted.
  • Lead and support Site QMS governance processes
  • Actively develop, mentor, train and enforce a site GMP culture within Operations.
  • Support regulatory and customer audits of the Operations areas and processes
  • Identify opportunities for GMP compliance training and awareness campaigns – design, develop and deliver.
  • Drive continuous improvement and ‘fitness for purpose’ for the PQS.
  • Deputise for PQS group lead
  • Ensuring technical accuracy and GMP compliance

What we need you to have:

  • Degree (or equivalent) in Biology.
  • Previous work experience in QA / GMP is essential.
  • Experience working with Quality Systems such as Trackwise and Document management system.
  • Experience managing Quality Records to completions
  • Experience working with teams to make improvements the Quality management systems such as deviations
  • Project management experience desirable
  • Demonstration of workload prioritisation skills, decision-making and scheduling skills.
  • Ability to meet strict deadlines.
  • Developing decision-making and problem solving skills.
  • Good organisational & planning skills.
  • IT literate - MS Office – Word, Explorer, Excel, Access, Outlook.
  • Database familiarity with data entry/searches / queries.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.  

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R28032