QA Expert / Senior QA Specialist Instrument Qualification, DPS

Executes establishment and maintenance of Equipment Qualification System at DPS. Ensures the proper qualification of equipment/instruments/computerized-systems by ensuring adherence to the corresponding VMP(s). Acts as first contact for equipment qualification & maintenance within QA; e.g. author of overarching documents around instrument qualification, overall qualification strategy for complex systems. Acts as first contact concerning equipment qualification document life cycle management; e.g. approval of instrument SOPs, qualification protocols and reports, periodic review documents. Act as first contact concerning compliance issues for equipment qualification in shared global systems (e.g. LIMS, DMS, Trackwise). Supervises and executes compliance activities e.g non-conformities, change request, deviations, CAPAs, audit/inspection/self-inspection observations, document management; participation in audit/inspection/self-inspection. Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement training and development plans.

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.

• Bachelor/Master Degree or equivalent experience in natural sciences (e.g., Chemistry, Engineering, natural science, or related field)

• Significant experience with (computerized) lab instrument qualification, quality records, and controlled document lifecycle management in a EU and US GMP regulated environment

• Familiarity with ISPE GAMP5 Guide and USP 1058 required

• Experience in the usage of LIMS, DMS, Trackwise, SAP, ELN

• Good communication and ability to work independently in a team, proactive and dedicated attitude

• Excellent knowledge of written and spoken English