QA Technical Specialist

QA Technical Specialist
Job Overview
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.

Main responsibilities:

• 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.