Associate Principal QA Specialist QADS
Location: Slough, UK
Today, Lonza is a global leader in life sciences operating across five continents. 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.
Join our outstanding team at Lonza and help drive our continuous improvement efforts. As an Associate Principal QA Specialist in our QADS team, you will play a vital role in maintaining quality processes in the UK.
Key responsibilities:
* Provide QA review and oversight for various studies and activities, including MSAT Studies, Pilot Studies, and Development Services.
* Conduct QA reviews of QC activities such as Method Validation, Reference Standards, and Stability Studies.
* Support Change Requests from focused areas and conduct Audit Trail Reviews.
* Approve, track, and trend deviations, atypical results, out-of-trend (OOT) results, and out-of-specification (OOS) results.
* Conduct area walkthroughs and ensure protocols are audited and approved in accordance with project schedules.
* Identify non-compliance with procedures and regulatory requirements, resolve necessary amendments, and determine follow-up actions.
* Mentor and coach business partners in cGMP practices, maintaining and developing a cGMP environment and quality culture.
* Lead core GMP training sessions and process audits.
* Actively identify and participate in continuous improvement activities.
Key requirements:
* BSc or equivalent experience in Biology or a related field.
* Advanced experience (5-10 years) in a QA / GMP role within the pharmaceutical industry.
* Excellent decision-making, problem-solving, and organizational skills.
* Demonstrates a strong focus on quality with a proven track record of implementing quality processes.
* Outstanding communication skills, both verbal and written.
* Ability to meet strict deadlines and work effectively within a team-oriented environment.
* Reliable, flexible, and well-motivated with a responsible attitude.
Join us at Lonza and be part of an outstanding team dedicated to building a positive impact on millions of lives worldwide. Your expertise and dedication will help us achieve our mission successfully. Together, we can develop a healthier world!
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.
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