Quality Compliance Specialist
CareerWise Recruitment
Dublin
A Quality Compliance Specialist is required by Careerwise recruitment to work with our Dublin based pharmaceutical client. THE ROLE: * Ensuring GMP-impacting systems are maintained as per written procedures. * Becoming a key member of the audit / inspection teams during external cGMP audits and inspections, e.g., corporate audits and regulatory authority inspections. * Assisting in implementation of Global Standards and Procedures into the site Quality Management Systems. * Actively supporting the development and implementation of continuous improvements to the QMS. * Participating in Quality Risk Assessments periodic reviews. * Oversight and preparation of Key Performance Indicators to align with company and global quality objectives. * Assisting in and facilitating completion of deviation investigations as part of the site Deviation Management System, ensuring effective root cause analysis and appropriate CAPAs. REQUIREMENTS: * Bachelor's degree in chemistry, biology or a related scientific discipline. * Experience working in sterile / aseptic manufacturing pharmaceutical facilities. * A minimum of 7 years working within Quality in the pharmaceutical industry. * Thorough understanding of sterile / aseptic manufacturing guidelines, the Pharmaceutical Management Systems guidelines, cGMPS, EU / US / JP guidelines. * Lead Auditor training and experience leading internal audits. * Knowledge of finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, process development, and manufacturing operations. N.B. It is essential that you hold a valid working visa for Ireland. Please call Michael O'Connor today for further information on 091-452410 or email moconnor@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.
329 days ago