Senior QA Specialist, Bioconjugates 80-100% (f/m/d)

Location

Location: the actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. The site in Visp, Switzerland is growing and for our Biologics Quality organization, we are currently looking for a Senior QA Specialist (f/m/d) for the Bioconjugates plant.

What you will get

• An agile career and dynamic working culture
• 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

What you will do

• Support continuous improvement programs to establish effective Quality Management System in Bioconjugates.
• Partner closely with cross-functional teams to identify risks, drive deviation management & continuous improvement.
• Guide and influence stakeholders by providing QA expertise, ensuring robust quality culture and operational compliance.
• Manage and actively participate in QA on the floor program, including QA walkdowns and GEMBA walks.
• Act as QA SME in meetings with the relevant stakeholders, and customers, in audits and inspections.
• Responsible for the review and final release of records like Standard Operating Procedures (SOPs), Deviations, Change Requests, Effectiveness Checks, risk assessment etc.
• Identify emerging QA relevant topics, communicating to the relevant stakeholders and working actively on their development into new or already established Quality and Compliance strategies and/or standards i.e., CAPAs.
• Train and coach new employees and existing QA Specialists.

What we are looking for

• Academic degree in Chemistry/ Biotechnology/ Life Science or related field.
• Extensive experience in the GMP-regulated pharmaceutical industry including continuous improvement within QA area required.
• Green Belt certification is an advantage.
• General knowledge of manufacturing processes, great understanding and knowledge in Deviations, CAPA and Change Request management including related activities.
• Demonstrated ability to act proactively with a detail-oriented, problem-solving and continuous-improvement mindset.
• Write, review and approve documents e.g. SOPs and other Quality documents as applicable.
• Experience in the interaction with health authorities (Swissmedic, FDA etc.) is desired.
• We are looking for someone who is independent, sociable, pro-active, customer focused and who values working as a team player.
• Experience as a QA trainer or trained as a trainer for Quality topics is an advantage.
• Experience with TrackWise, SAP, and Microsoft Office software is preferred.
• Fluency in English is required; German would be an asset.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Every day, our teams across the world work together to turn scientific breakthroughs into life-changing medicines that reach up to 100 million patients a year. Lonza is a place where people can make a unique impact, grow their careers and belong. You will feel at home at Lonza if you: Take ownership, step forward, and enjoy meaningful responsibility Love solving problems and thrive in a complex, fast-moving environment Are curious, always looking to learn and improve Work collaboratively, contributing to something bigger than yourself Are motivated to make a difference through work that impacts customers and their patients.

Why Lonza: We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, you will have the freedom to grow, the support to succeed and the chance to contribute to work that matters. We are the makers of the medicines of tomorrow. Join us. Be you.

#J-18808-Ljbffr