Quality & Regulatory Specialists (Pharma, Cork)

CareerWise Recruitment

Cork

QUALITY & REGULATORY SPECIALIST with a minimum of 3+ years QA experience in the Pharma industry and some Regulatory experience required by CareerWise Recruitment for our multinational generic pharmaceutical client in Cork. The QUALITY & REGULATORY SPECIALIST will be primary responsible for quality systems, quality assurance, supplier due diligence, compliance with cGMP's, new product introduction and maintenance of existing finished products including brand guidelines and artwork for SGS Private Label. THE ROLE: * Ensures compliance with cGMP's & Environmental, Health & Safety regulations. * Ensure compliance & execute all activities to the Quality Management System such as non-conformance investigations; deviations; change control, complaints, document control system, record retention & 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 & compliant launch of finished products. * Manages & executes all routine regulatory updates & submissions of finished product labelling. * Creation and maintenance of National Drug Codes (NDC) & Universal Product Codes (UPC. * Creation and maintenance of Structured Product Labeling (SPL) for FDA submissions. * Ensures the company and product is registered in the appropriate markets & with agencies as required. * Reviews and approves product labeling, patient package insert and other product labeling. * Executes the document control system & 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 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. * Excellent problem-solving skills to evaluate quality problems and apply knowledge to identify appropriate solutions. * Ability to apply critical thinking on review of all quality related procedures and documents. * Excellent attention to detail. * Artwork review/Regulatory 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 Conor Twomey today for further information on 087-0907204 or email: ctwomey@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.

624 days ago