QA Technical Specialist
CareerWise Recruitment
Waterford
A QA Technical Specialist contractor is required by CareerWise Recruitment for our Waterford based Biopharmaceutical and Medical Device Client. The QA Technical Specialist reports to the QA Manager providing leadership, knowledge, expertise and hands on support for the introduction of a new MES system at the client site. The position works closely with Operations and MES functions to design, install, evaluate and qualify a MES system fit for use. THE ROLE: * 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, CAPAs, 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. REQUIREMENTS: * Experienced QA Candidate. * Batch review experience. * EBR experience. * Change Control process knowledge. * QA Projects knowledge. Please call Aisling O'Hagan-Yil today for further information on 021- 2427410 or email: aohagan-yil@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.
579 days ago