Senior QA Specialist, QA Operations

Coordinate QA interests during different project phases. Responsible for project specific QA Operation tasks during Commissioning / Qualification. Responsible for review and final release of records such as Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Quality Risk Assessments, Deviations, CAPAs, Change Requests, Effectiveness Checks, Testing Protocols & Reports…etc. Managing independently stakeholders and their needs in a customer focused environment. Participate and support regulatory inspections and customer audits.

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 Biotechnology/ Biochemistry or a related field.

• Significant experience in biopharmaceutical manufacturing, preferably in a QA function.

• Strong background in cGMP and broad knowledge in biotechnological manufacturing processes, validation approaches and risk management.

• Sound experience in representing Quality and Compliance in projects.

• Good communication skills and experience in interaction with all kind of interfaces within the organization.

• Experience in the use of the following systems would be preferred: TrackWise, LIMS, DMS and SAP.

• Excellent written and spoken English - knowledge of written and spoken German would be an advantage.