Quality & Regulatory Specialist

Careerwise Recruitment

Munster, Cork

QUALITY & REGULATORY SPECIALIST required by CareerWise Recruitment for our Cork based client. The QUALITY & REGULATORY SPECIALIST will be responsible for regulatory affairs, quality systems, compliance with cGMP's, in addition support release of finished product and investigation of product issues. THE ROLE: * Ensures compliance with cGMP's & Environmental, Health & Safety regulations. * 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 finished product non-conformance process. * Supports the timely receipt and release of finished products. * Executes the document control system & record retention. * Supports document reviews to ensure timely release of finished product. * Develops, implements and maintains Standard Operating Procedures. * Ensure compliance & execute all activities to the BluePoint Laboratories Quality Management System such as non-conformance investigations; deviations; change control, complaints, document control system, record retention & CAPA. * Measure key performance indicators (KPIs) to monitor areas of responsibility and identify areas for improvement. * Maintain familiarity with current regulatory trends. * Establishes and promotes the maintenance of a safe, accident free and healthy work environment. * Performs related duties as assigned. REQUIREMENTS: * BS in a scientific discipline preferred. * Minimum of five (5) years in a cGMP facility in a Regulatory/Quality Assurance role. * Essential to have good communication and attention to detail. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin. Supporting Business Demands & Growth since 1999. CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times. This job originally appeared on RecruitIreland.com.

2381 days ago