Lonza
QA Specialist, Batch Record Review 80-100% (f/m/d)
Location: Visp, Hybrid Work Model. Relocation assistance is available for eligible candidates and their families, if needed.
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.
The QA Specialist, Batch Record Review reports to the QA Operations Group Lead, working in close collaboration with different Quality and multiple Operations functions in order to ensure cGMP-compliant manufacturing activities and documentation within the organisation.
What you’ll get:
An agile career and dynamic working culture
An inclusive and ethical workplace
Compensation programs that recognize high performance
A variety of benefits dependant on role and location
The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits.
What you’ll do:
Review of the Executed Batch Records (e.g. production documentation review, raw data etc)
Support batch release by ensuring the completeness of the documentation package
Review comments added to the Executed Batch Records, clarify with the operations team and evaluate with the responsible QA Manager
Support the initiation of deviations and investigations for Batch Record review related observations
Collect and evaluate on a regular basis KPI data
Write and revise SOPs in his/her area of expertise
What we’re looking for:
Academic degree OR relevant work experience in Biology/ Chemistry/ Biotechnology or other related field
Previous experience in GMP regulated pharmaceutical / API industry is an advantage
Ability to identify non-compliance and gaps from quality standards
Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
Fluent English (written and verbal) is required, German language skills preferred
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.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.