Quality Specialist

Quality Specialist - Carlow. Super opportunity in Carlow with Pharmaceutical company for a Quality Specialist Role: Support Engineering activities through documentation generation, equipment and process investigations associated with GMP activities and completion of quality notifications. Be a document system expert; this will include document review, approval and document system work flow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOPs, SWIs, training documents, and change controls. Raise CAPA's and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 whys etc.; implement subsequent corrective action through the change management system. Required to comply with the company's Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions. Support and lead Internal Quality audits of Engineering Dept. Assist in the management and/or assignment of Engineering training if required Degree qualification or equivalent Min Level 7 (Science, Engineering, Technical). o Excellent communication, presentation and interpersonal skills, to interface effectively with levels of colleagues and with external customers in a team orientated manner o Excellent training, facilitation and assessment skills o Demonstrable analytical and systematic problem solving skills o Strong influencing skills o Flexible approach o Effective time management and multi-tasking skills o Proven organizational skills o Excellent attention to detail o Trouble shooting skills o Goal/results orientated Skills: compliance Documentation Quality SAP