QC Specialist

Job description

Your mission As QC Specialist, you will be responsible for ensuring continued Good Manufacturing Practice (GMP) – compliant activities within QC to support the manufacture and release of plasmids and gene therapy products. This role will be a part of aiding the start-up of a new GMP facility for the production of gene therapy products. As such, it will involve participating in and providing subject matter expertise in equipment qualification, method transfer and routine in-process and release testing within the QC labs, in addition to other QC-supporting activities. Job Description: Responsibilities: - Support Technical transfer of the drug substance dilution to QC Shannon. - Bridging study for QC dilutions to compare dilution regime in QC to previous TFF to DS dilution. - Execution of dilution studies with including equipment installations and qualification. - Support QC stability studies are planned, effectively tracked, monitored and achieved in accordance with agreed timelines. - Support QC stability studies are implemented in accordance with international standards and relevant regulations. - Support for issues, CAPAs, Change Control, Action items and risk assessment within QC...