QA Technical Specialist
QA Technical Specialist
QA Technical Specialist opportunity for a world-renowned Pharma company that provides life-changing treatments & vaccines, Sanofi.
The QA Technical Specialist reports to the QA Manager providing leadership, knowledge and expertise and hands on support for the introduction of a new MES system at Sanofi Waterford. The position works closely with Operations & MES functions to design, install, evaluate and qualify a MES system fit for use.
- Perform the QA representative role in the development and implementation process of Manufacturing Execution System (MES) project.
- Review of MES documentation, recipes and process flows; supporting MES change control
- Complete the QA oversight to ensure the design and validation of the MES system meets cGxP, data integrity and site requirements
- Review and approval of MES validation documents
- Authoring, Review and Approval of cGMP Documentation associated with the MES project
- Act in a lead capacity providing quality support to a MES project working with other functions to deliver project on time and in compliance
- Support the development and implementation of Master Batch Records and procedures for existing product platforms (e.g. Auto Injector).
- Support the project team with defining strategies for change controls, risk assessments and UAT testing documentation
- Perform timely review of documentation / process maps / reports highlighting and assisting in the resolution of concerns commensurate with the risk.
- Liaising with both internal and external customers on quality issues.
- Participate in the preparation and review of procedures and batch documentation.
- Preparing and supporting MES systems for batch release.
- Provide training support to site TMs on quality related aspects of MBR process and actively participate in change management activities
- Working as part of a project team on site ensuring products are manufactured, in accordance with cGMP.
- Ensure that all work carried out is in compliance with the required standards conforming to company, cGMPs, cGLPs, SOPs, regulatory regulations and guidelines.
- Review and approval of deviation, CAPA's, quality events, change controls and tasks.
- Acts as Quality Point person providing guidance / feedback on quality issues/concerns.
- Analysing, identifying and implementing quality and operations process improvements which will improve process capability and performance.
- Actively contribute to continuous improvement initiatives.
- Conduct duties in a safe manner and report all safety issues or concerns.
This is an experienced QA role with requirements of batch review and EBR experience.
Knowledge of Change Control process and QA projects.