Senior QA Specialist, Clean Utilities and Environmental Monitoring

Comply with, Develop, implement and monitor quality procedures to ensure compliance with GxP standards, corporate policies, Swissmedic, FDA and other regulatory body regulations and guidelines. Support all QA operations activities concerning SOP landscape, electronic batch records, training, deviation- / CAPA- and change control management. Support all audits and inspections. Identify and implement Lean / OPEX approaches in Quality and foster improvement projects. Provide KPI reporting and execute action plans to address opportunities for improvement. Work collaboratively with QA Operations and QA department colleagues.

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.

• Academic degree in a Life Science discipline/ Engineering/ Quality Management or related field

• Experience in working on a regulated Medical device, Drug product or Drug Substance site

• Experience with Lean / Operational Excellence / Six Sigma

• GMP compliance expertise

• Ability to interface and communicate directly with customers and regulatory bodies

• Excellent written and oral communication to include accurate and legible documentation

• Ability to work on call and/or out of normal working hours on site

• Fluency in English is required, German language skills are an advantage