Job Description
QA Specialist On Site - Carlow Shift role AMC21988 We are currently looking for an experienced QA Specialist for an exciting role with a rapidly growing biopharmaceutical manufacturer based in Carlow. You will be responsible for ensuring manufacturing of drug products are complaint with cGMP and associated regulatory requirements. If you have a third level degree along with 3-5 years experience in pharmaceutical manufacturing including Quality and GMP auditing this could be the role for you. Responsibilities Review of batch documentation, SOPs, Cleaning verification and validation data Support development and implantation of improved quality documentation and procedure Provide real time shop floor support for daily manufacturing operations Quality input into shop floor decision making Provide training in all aspects of QMS and GMP Aid the effective implementation of the Quality Management System and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete; review on a continuous basis. Be an advocate of continuous improvement in the Quality Management Systems. Actively participate in Plant/Quality committees and works with other site functional groups, such as the Microbiology Laboratory, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives. Contribute to continuous improvement initiatives and ensure the department maintains inspection readiness Maintain self inspection program and continuously monitor quality systems Requirements Third Level Degree qualified in a Science/Technical or related discipline. Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment. Knowledge of US and European cGMP guidelines, and other international regulatory requirements, as applicable to the site. GMP Audit experience in the pharmaceutical industry If you are interested in this posting apply today and Angela from Life Science Recruitment will be in touch! Skills: Quality Assurance Auditing GMP