Today, Lonza is a global leader in life sciences operating across three 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.

In Visp, we are looking for a QA Specialist (f/m/d) to extend our team. You will report to the QA Operations Team lead Microbial and work in close collaboration with different quality and operations functions in order to ensure cGMP-compliant manufacturing activities and documentation.

Key responsibilities:

Owns all quality related responsibilities for the daily activities in the department to support API manufacturing processes for clinical and commercial supply:

• Responsible in full for adherence with the quality agreement provisions
• Responsible to ensure all deviations are appropriately investigated and recorded.
• Responsible to drive CAPA items to complete and timely completion
• Directs the investigations of customer product complaints and assures the completion of the appropriate documentation
• Performs assessments for all product-related changes, assess relevance to regulatory filings, decide to implement and provide change controls for approval to customers where required
• Ensures an efficient cGMP compliant life cycle management of all products manufactured
• Has the authority to make quality decisions for the project in internal and external meetings

Execute quality compliance activities:

• Compiling, verifying and final release of records like Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.
• Ensures that document are correct, adhere to information filed to the authorities and that revisions/reviews are done in a timely manner
• Assesses project-specific risks and internal adherence to cGMP by identifying areas of non-compliance through risk assessments and internal & external audits; SME for clients audits and participate in regulatory inspections of health authorities

Single client contact point for all project related quality requests:

• Providing cGMP guidance to all Lonza departments engaged in the production of active pharmaceutical products
• Works with our customers to ensure their Quality questions are answered and all quality relevant items are communicated to the clients in a timely manner
• Quality lead in weekly phone calls and during customer visits

Other activities like:

• Supports cGMP training programs to ensure all staff is being trained
• Trains and mentors junior Lonza employees to better accomplish and perform in their duties as quality professionals

Key requirements:

• Bachelor or Master of Science in life science (e.g. chemistry, biotechnology or other related field)
• Experience in the GMP regulated pharmaceutical / API industry is an advantage
• Ability to identify non-compliance and gaps from quality standards
• Experience collaborating closely with different functions and departments
• Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive.
• Fluency in English language and basic German skills are an advantage

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.