This position will be part of the CMO Quality group responsible for representing Shires Quality function during qualification and validation activities related to cold chain/controlled temperature shipments and CMO drug substance & product manufacturing / packaging operations and will involve.
In this role, the selected candidate must have an excellent understanding of 21 CFR Part 11, ICH standards, EMEA, GLP, GCP, GMP, GDP regulations, GAMP Methodologies and general software development standards.
In this role, the successful candidate will work constructively with cross-functional departments for timely resolution of quality issues; support activities and documentation related to corrections, corrective actions and preventive actions to correct and eliminate the potential for non-conformances.
In this role, the selected candidate will act as a QA representative on associated projects related to Quality laboratory operations; ensure clear communication on issues and timely escalation as applicable.
In this role, you will support the organization in monitoring of the compliance of laboratory testing, manufacturing, and clinical research and ensuring continued effectiveness of the QMS according to CLIA, CAP, HIPAA, GLP, GMP, and QSR requirements.