Compliance Specialist

CAREERWISE RECRUITMENT

LIMERICK

A Compliance Specialist is required by CareerWise Recruitment for our Limerick based client. The Compliance Specialist, Drug Product Manufacturing is a member of the Drug Product Manufacturing Team and is responsible for operations support and compliance related activities. THE ROLE: * Lead and manage deviation investigations, CAPAs, and change controls. * Reviewing and maintain procedures, polices and other instructional documents with a focus on continuous improvement. * Responsible for generating and tracking performance metrics. * Maintains knowledge of current good manufacturing practices cGMPs. * Responsible for periodic reviews of Drug Product Manufacturing documentation and records to assess for compliance with established quality standards, policies and procedures. * Assist in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers. REQUIREMENTS: * Specialist; minimum of BS/BA in scientific discipline with 2 years of related experience in cGMP manufacturing. * Knowledge of drug product manufacturing from formulation through the final package. * Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations. * Experience in collaborating with CMOs/CROs is preferred. Please call Lisa Casserly today for further information on 091-339136 or email: lcasserly@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.

1647 days ago