QA CSV Engineer
A QA CSV Engineer is required by CareerWise Recruitment for our Cork based med device client.This is a 12 month initial contract role . Please contact Diarmuid Buckley for full details. THE ROLE: * Ensure computer system validation activities completed are compliant with internal procedures and external regulations and standards. * Review and approve documents prepared by project teams, other departments and contractor organizations (e.g. protocols, reports, change controls. * Assist in development of validation strategy and validation plan for computer system validations. * Assist in resolution of deviations/ exceptions during qualification activities. * Assist with change control activities in accordance with site procedures. * Attend identified training required to fulfil the role of QA Computer System Validation Engineer. * Support the QA Validation team leader in driving improvements within the Validation and Change Control processes to streamline the validation activities associated with system changes and new technology development. * Participate in cross-functional teams as required. REQUIREMENTS: * Hons. Degree Quality/ Manufacturing / Engineering / Science or related field. * Minimum 2 years of related industry experience. * Minimum of 3 years' experience with automated system development or operation. * Strong knowledge of Quality systems (FDA/ISO) within a regulated environment including 21CFR Part 11. * Strong knowledge of system development life cycle and GAMP. * Validation experience with automated manufacturing system. Please call Diarmuid Buckley today for further information on 021- 4355432 or email: email@example.com. CareerWise Recruitment (In Search of Excellence. CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Ireland's leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin. Supporting Business Demands & Growth since 1999. CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times.
20 days ago