Quality And Regulatory Specialist

CareerWise Recruitment

Cork

A Quality and Regulatory Specialist is required on a PERMANENT basis by CareerWise Recruitment for our client; a Cork-based Generic Pharmaceutical Drugs Company. Under general direction of the Quality & Regulatory Manager, the successful candidate will be primary responsible for quality systems and quality assurance activities, compliance with cGxPs, in addition with supporting release of finished product and investigations of product related issues and regulatory affairs. THE ROLE: * Ensures compliance with cGMPs and Environmental, Health & Safety regulations. * Ensures compliance and executes all activities to the Quality Management System such as non-conformance investigations; deviations; change control, complaints, document control system, record retention and CAPA. * Executes the finished product non-conformance process. * Supports document reviews to ensure timely release of finished product. * Executes all regulatory updates to product labelling to ensure timely and compliant launch of finished products. * Manages and executes all routine regulatory updates and submissions of finished product labelling. * Creation and maintenance of National Drug Codes (NDC) and Universal Product Codes (UPC. * Creation and maintenance of Structured Product Labelling (SPL) for FDA submissions. * Ensures the company and product is registered in the appropriate markets and with agencies as required. * Reviews and approves product labelling, patient package insert and other product labelling. * Executes the document control system and record retention. * Develops, implements and maintains Standard Operating Procedures. * Measure key performance indicators (KPIs) to monitor areas of responsibility and identify areas for improvement. * Maintain familiarity with current regulatory trends. REQUIREMENTS: * Minimum requirement of a BSc in a scientific discipline. * Minimum of five (5) years in a cGMP facility in a Quality Assurance role. * Essential to have good communication and attention to detail. * Experience in the Pharmaceutical industry is essential. * Experience in Medical Device regulations is desirable but not essential. * Artwork review experience desirable. * Supplier Quality. * Quality Systems. * Computer literate; Excel, Word, Document Management System etc. * Excellent knowledge of Quality Systems, Quality Assurance, cGxP and regulatory affairs. 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.

450 days ago