QA Specialist

CareerWise Recruitment

Tipperary

QA Specialist required by CareerWise Recruitment for our multinational biotech client in County Tipperary for a 11 month contract. The Specialist is a member of a team within Quality and is involved in supporting the GMP Quality Assurance activities at the Tipperary site. THE ROLE: * Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification. * Perform and review complaints and deviation investigations, change controls and CAPA's. * Creates and maintains assigned SOPs. * Compiles data for reports and presentations, provides data interpretation draws conclusions. * Completes audits to ensure compliance to SOPs, GMPs and applicable regulations. * Support product recalls and stock recoveries as appropriate. * Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review. * Generally, follows standard procedures and consults with manager/supervisor on exceptions. * Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy, and safety in accordance with Company and regulatory requirements. REQUIREMENTS: * The Specialist is required to possess a degree in an Science or Engineering discipline plus some industrial experience. Alternatively, they must possess considerable industrial experience. Please call James Farrar today for further information on 0872489961 or email: jfarrar@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.

400 days ago