QA Technical Specialist

Summary:
A QA Technical Specialist is required for a biopharmaceutical company in Waterford. The successful candidate will provide support for the introduction of a new MES system at the site in Waterford. The position works closely with Operations & MES functions to design, install, evaluate and qualify a MES system fit for use.

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.

Qualifications & Experience:

• Minimum degree in Science or Engineering or related.
• Minimum 4-5 years’ working experience within a Quality Assurance role in a pharmaceutical environment.
• This is an experienced QA role with requirements of batch review and EBR experience.
• Knowledge of Change Control process and QA projects.
• MES systems experience.