- Our client is looking for a QA Technical Specialist to join their busy bio-pharmaceutical state-of-the-art facility in Co. Waterford.
- 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 the site in Co. Waterford.
- The position works closely with Operations & MES functions to design, install, evaluate and qualify a MES system fit for use.
Core Duties and 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.
Minimum Qualifications and Experience:
- This is an experienced QA role with requirements of batch review and EBR experience.
- Knowledge of Change Control process and QA projects essential.
- Third Level Degree in Sciences or Engineering discipline.
- No shift required for this role
- Detailed knowledge of cGMP pharmaceutical environment.
- Exemplary communication, dedication and keen focus on delivering key to success within the role.
To Apply: Quote – PE22117
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.