Associate Principal QA Specialist QADS

Lonza; Slough; On-site; GBP 50,000 - 70,000; Full time

Job summary

A global leader in life sciences is seeking an Associate Principal QA Specialist in Slough, UK. This role involves QA oversight of studies and activities, conducting QA reviews, and mentoring colleagues in cGMP practices. The ideal candidate will have a BSc in Biology and 5-10 years of experience in QA/GMP within the pharmaceutical sector. Join a team dedicated to continuous improvement and impactful work worldwide.

Qualifications

• 5-10 years of experience in a QA / GMP role within the pharmaceutical industry.
• Demonstrates a strong focus on quality with a proven track record of implementing quality processes.
• Ability to meet strict deadlines and work effectively within a team-oriented environment.

Responsibilities

• Provide QA review and oversight for various studies and activities.
• Conduct QA reviews of QC activities such as Method Validation and Stability Studies.
• Mentor and coach business partners in cGMP practices.
• Identify non-compliance with procedures and resolve necessary amendments.
• Lead core GMP training sessions and process audits.

Skills

Decision-making

Problem-solving

Organizational skills

Communication skills

Education

BSc in Biology or related field

Job description

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.