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Employer CPL
Job Title Quality Assurance Manager Cmo
Description

My client is a Global Biotechnology company based in Dublin City Centre and are looking to recruit for a Quality Assurance Manager CMO for their commercial operations based in Dublin City Centre.

Role will involve :

  • Initiation, execution and tracking of Incident Escalation with facilities, Operating Unit and Executive Management. Assures decisions are adequately documented, filed, and executed. 20%
  • Initiation, execution and tracking of Field Corrective Actions, Biological Product Deviation Reports, Field Alerts, Product Defect Report and Corporate Product Holds. 20%
  • Review and compile documentation associated with Post Market Surveillance issues.10%
  • Communicate and follow-up with internal, CMO, LOC, and new sites or acquisitions associated with Post Market Surveillance actions. 10%
  • Initiation and closure of Corporate Product Holds.10%
  • Preparation of various tracking matrix for monthly and quarterly reviews.5%
  • Preparation of presentation for various monthly and quarterly reviews. 5%
  • Support in procedural revisions.5%
  • Participate in internal and external inspections as required. Support with timely closure of observations and audit items.5%
  • Assist and guide facilities with Post Market Surveillance issues. 5%
  • Participate and/or lead Post Market Surveillance related projects, 5%
Essential:

  • Bachelor's degree in science or engineering
  • Minimum of 5-8 years of experience in a Quality role in the biopharmaceutical/pharmaceutical industry
  • Minimum of 3 years of management experience

Suitable applicants should email their cv to aileen.cahill@cpl.ie or call me on 01-6146007 for a confidential conversation today .

This job originally appeared on RecruitIreland.com
Location Dublin City Centre
Date Added 6 days ago
Apply Link
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