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Pe Global

Job Title

Quality Engineer - QA Department


PE Global are currently recruiting for a Quality Engineer for a client site in West Dublin: POSITION SUMMARY Responsible for the document control process at the Dublin site and supports documentation requirements for the EMEA QMS. This role will involve working closely with the Quality Management representative, the management team, the internal audit team and all departments covered by our QMS. Responsible for Healon Release, Supporting Regional Ship Hold process, approval of Sterility Certs, Promotional Build Process and EMEA Labeling activities, CAPA responsibility related to these activities. QE will also support Global RQO projects. ESSENTIAL FUNCTIONS / RESPONSIBILITIES Responsible for the document control process at clients site in Dublin and supports documentation requirements for the EMEA QMS. Assists in the preparation of QA KPIs and participation in site Management Review. LMS administrator for QA function and co-ordinator for the Dublin site (30%) Responsible for the EMEA internal audit program and participates on the Division Audit team. Participates as a member of the Division Audit Program. (10%) CAPA coordinator for Dublin site. Schedules, chairs and reports for the CAPA Review Board and responsible for coordination of CAPA certification training. (10%) Responsible for product release in the ERP system as required by TPMs. Support EMEA Marketing with Promotional Build activities for the EMEA region. Support customer Support Export activities as required to ensure timely approval of Sterility Certificates and other paperwork as required. Supports Division QA with Product Hold activities as required. (50%) QUALIFICATIONS At least 3-5 years in Quality Assurance or another function in the pharmaceutical, medical device, nutritional or related industry experience. Ability to travel up to 20% required. Personal skills needed include tact, open-mindedness, self-reliance and sound judgment. Persuasive, effective communication skills are essential with an ability to work effectively across site and technical areas. Individual must have excellent oral and written communication skills. Interested candidates should send their CV to Audrey Brennan - or call 0214297900. This job originally appeared on



Date Added

103 days ago