Quality Control Consultant

ABOUT THE JOB

• Lead and execute strategic QC assessments, gap analyses, and remediation projects for biopharmaceutical clients (including mAbs, recombinant proteins, vaccines, and advanced therapy medicinal products).


• Advise on cGMP compliance (FDA, EMA, PIC/S, Health Sciences Authority) with a focus on laboratory practices, data integrity (ALCOA+), and quality systems.


• Support clients in preparing for and responding to regulatory inspections (pre-approval, routine, and for-cause).


• Conduct root cause analyses and lead investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), and laboratory deviations.


• Review and optimize analytical method validation, transfer, and verification protocols and reports.


• Assess and improve laboratory document management systems, inc...