QA Document Control Associate

Sigmar Recruitment

Cork

My client is a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. This role requires ahigh level of initiative, energy and motivation as well as organizational skills. The role as a QA Document Control Associate would see you reporting to the Quality Systems Team lead and maintaining functional responsibility for oversight of Site Documentation, Documentation system and Archive activities in a cGMP regulated environment. Responsibilities- But not limited to: Oversee all aspects related to controlled document mastering, issuance, distribution and storage in a GxP environment, including Commercial and Clinical batch records, SOPs and forms. Maintain technical agreements with external service providers. Maintain technical reports. Perform routine internal audits to ensure compliance and continuous process improvement. Oversee employee training on GDP and the electronic document system. Coordinate external document storage activities and maintain related contracts. Other duties as assigned. Education. Minimum of a college or university diploma. Equivalent experience may be considered. Experience. 5+ years experience in a cGMP regulated manufacturing environment with exhibited knowledge or proficiency in Document control and related systems. Good knowledge and understanding of GMP requirements and guidelines. Proficiency with technical summary report generation required, with exceptional organizational and Computer skills preferred. For more information please call Leah on 021 4847 135 or send your CV to loflaherty@simar.ie. This job originally appeared on RecruitIreland.com.

2171 days ago