Our client is looking for a Deviation Quality Specialist based in Dublin.Responsibilities:With energy and enthusiasm, the Quality Ops Deviation Specialist will:- Will serve as a Quality SME for site deviation management system. - Support the review and approval of site deviation and investigations reports. - Ensure root causes have been identified and corrective action implemented and can demonstrate basic knowledge of six sigma, LEAN, and root cause analysis tools used for- Day to day management of Deviation and CAPA metrics- Support internal and external audit preparations regarding deviation management system- support the delivery of site deviation training - Support global meetings and activities for site deviation management system - Works directly with cross-functional departments to ensure that quality system requirements are met.- Performs other duties assigned by Management.Qualifications and experience:General- This role requires a minimum of some years' experience in, Quality Assurance, Technical Operations or Engineering within the Biopharma / Pharmceutical industry. - A self-starter and results-focussed, the successful candidate will have strong contemporary- knowledge of relevant cGMPs, regulations and current industry trends relating to deviation investigations and CAPA identification.Technical- Experience working in regulated environment with exposure in the Regulations & guidance's - GMP, CGMP, GAMP, 21 CFR Part 11- Must have at least 3 years of experience of deviation systems and investigations in a regulated environment. - Must have experience of compiling and reporting QMS metrics. - Experience with SAP desirable. People- The motivation to be an inspiring member of a high performing team.- The desire to continuously learn, improve and develop- A great communicator, decisive decision maker and proven ability to deliver excellence- Confidence to direct off-site suppliers to the project, willingness to support the team and a laser light focus to deliver excellence- Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.- Experience with new product introductions and/or process qualification/technology transfer - Detail oriented and meticulous worker. If you would like to hear a little bit more about it, please email me your CV to email@example.com or apply in the link below.