The actual location of this job is in Basel Stücki, Switzerland.
For our successful Drug Product Services (DPS) focused branch located in Basel and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the QA Expert/Senior QA Specialist Instrument Qualification position.
What you will get:
An agile career and a dynamic work culture
An inclusive and ethical workplace
Compensation programs that recognize high performance
What will you do:
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
What we are looking for:
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
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.
Ready to shape the future of life sciences? Apply now.
Lonza is a pioneer and world leader in the CDMO industry, setting the pace with cutting-edge science, smart technology, and lean manufacturing. United by a common purpose, we turn our customers’ breakthrough innovations into viable therapies and manufacture the medicines of tomorrow.
Founded in Switzerland in 1897, our company is the first and original CDMO, and today we are more dynamic, agile and forward-focused than ever before. As one of the largest Western CDMOs, we bring together a global team of around 18,500 colleagues across five continents to deliver comprehensive, integrated solutions for our customers' complex needs.
For our customers and their patients, we bring quality, safety and reliability to bring life-enhancing and life-saving treatments to market at speed and at scale. For our colleagues, we strive to create a sense of belonging and inclusion where every person can thrive and bring their best.
