Senior Specialist QC - Quality Systems

• Lead and manage QC investigations, including OOS results, deviations, non-conformances, and laboratory investigations

• Perform and document Root Cause Analysis (RCA) and drive problem-solving initiatives

• Own and support CAPAs, including implementation, risk-based assessments, tracking, and effectiveness reviews

• Manage QC Change Control activities for new analytical methods, instruments, and QC systems

• Participate in global investigations as required and present outcomes to senior stakeholders

• Support operational excellence initiatives and continuous improvement projects

• Contribute to innovation in QC, including adoption of digital solutions and AI

• Support audits and inspections, providing documentation and read-outs as required

• Minimum 3 years' experience in a GMP-regulated environment

• At least 1 year hands-on experience in QC investigations

• Minimum B.Sc. in Biochemistry or a related discipline

• Strong understanding of investigation processes, RCA methodologies, CAPAs, and GMP documentation

• Experience working with or supporting CAPAs

• Strong communication skills and confidence engaging with senior stakeholders

• QC Change Control experience

• Background in continuous improvement or operational excellence initiatives

• QC laboratory experience (manufacturing investigations also considered)

• Knowledge of biologics QC testing (separations, bioanalytical, microbiology, raw materials, stability testing)

Next Generation