Continuous Process VerificationGLPcGMPProcess capability analysisRoot cause analysisFillingNon-sterile manufacturingrisk assessmentsCAPA managementCross-Functional LeadershipGood Manufacturing Practice (GMP)Data Analysis
Languages
English
The role
03
01Manage manufacturing or complaint investigations on product impact, including root cause analysis, CAPA generation, and impact assessment
02Support the process capability analysis and Continuous Process Verification of key quality attributes and parameters at the different CMOs
03Provide Impact assessments of change requests
04Support of review of technical documents and data verification activities
Requirements
↳scientific or engineering degree
↳3-5y experience in commercial manufacturing of sterile drug products
↳Experience in parenteral compounding and filling
↳Involvement in deviations, CAPA’s and risk assessments (FMEA)
↳Understanding of process, engineering, analytical and regulatory aspects of sterile drug product manufacturing
↳Your solution-oriented approach allows you to communicate and negotiate in an effective way
