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Employer CPL
Job Title QA Specialist
Description

QA Specialist
Reporting to: QA Manager
Company: multinational manufacturing company
Location: Galway
The Role

  • Support Annual Reports submission, Product Development and Product Launch.
  • Review of stability data. Support the Sites in investigating laboratory OOSs.
  • Support of Investigation of product complaints, OOS and non-conformances of Affiliate Sites & Associated Vendors.
  • Review of Product Quality Review Reports
  • Provide Technical Transfer and Process Validation Support.
  • Review equipment, process, method validation protocols and reports, and stability protocols and reports.
  • Review of Technical Agreements and Confidentiality Agreements.
  • Provide training to Regional QA staff & QA Affiliate staff at the relevant manufacturing & packaging site in GMP practices and procedures when required.


Criteria for the position:

  • Minimum of a Bachelor's degree (or equivalent) in science or pharmacy
  • 5+ years of experience in quality control or quality assurance within a GMP environment.
  • Must possess knowledge and experience of all quality system aspects including: Deviation management, CAPA, Complaint handling, auditing, change management, supplier qualification, and batch release.
  • Experience in troubleshooting within a QC laboratory background is desirable.
  • Knowledge of Validation and Aseptic manufacturing an advantage but not essential.
  • Knowledge of Pharmaceutical QMS Systems and of Quality Risk Management Systems.
  • Knowledge of cGMPS i.e., USFDA, 2003/94/EC, MHRA and WHO.
  • Knowledge and experience in the use of Data Sharing Software Packages an advantage.
  • Periodic travel may be required.

Interested candidates please contact Annette Murphy on 091 507515 or email your CV in confidence to annette.murphy@cpl.ie



This job originally appeared on RecruitIreland.com
Location Galway
Date Added 8 days ago
Apply Link
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