In this role, the selected candidate will work on problems of diverse scope where analysis of data requires evaluation of identifiable factors; networks with senior internal and external personnel in own area of expertise.
In this role, the selected candidate will prepare appropriate documentation and executes release of acceptable vendor materials; review completed analytical data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
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, you will assume responsibility for risk assessment and risk reduction activities, including assimilation analysis and presentation of data. Monitors trends in areas of concern. Acts as a resource to medical staff and departments on areas of quality and risk management/improvement and other related areas of expertise.
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.
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 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 selected candidate will review and ensure related FMEA session presentations adhere to ASML requirements; facilitate FMEA Brainstorm sessions guiding cross functional groups to effectively identify pertinent risks.