Quality Auditor - Carlow

Pe Global

Carlow

PE Global is currently recruiting for a Quality Auditor for a Client site in Carlow - Responsibilities: The Quality Auditor conducts routine audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure the compliance with SOPs and GMPs and worldwide regulations. Review and approve production and analytical documentation accompanying the release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements. In addition, the Auditor communicates and resolves audit comments with client areas. Under supervision, or as part of a team, perform audits or inspections of assigned areas or systems to assess compliance with regulatory and Company standards. Issue reports summarizing deficiencies and work with areas to execute remedial action. Notify appropriate management of inspection result. Works with moderate work direction and is skilled and knowledgeable to the position. Qualifications: Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations. Effective communications (oral/written) and interpersonal skills are necessary. Interested candidates should submit an updated CV, marked for the attention of Audrey audrey.brennan@peglobal.net or 00353 21 4297900. This job originally appeared on RecruitIreland.com.

2294 days ago