QA Associate

  • Cork
  • Temporary 23 months
  • JO-1711-63026_1551955822

Summary

Responsibilities

  • Review of Manufacturing/Packaging batch records and Quality Control records prior to recommending release of batch.
  • Review and approve standard operating procedures (SOPs) and master batch records.
  • Review deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented.
  • Assist with periodic audits and reviews of contract manufacturers to ensure compliance with cGMPs and other regulatory requirements.
  • Assist with the oversight of the supply chain, manufacture and packaging of products in various Contract Manufacturing Organizations.
  • Assist with regulatory inspections.
  • Artwork Approval
  • Support the following activities, as appropriate:
  • Processing external complaints
  • Quality Deviations and Laboratory Investigations
  • Change Controls
  • New or updates to relevant quality agreements
  • Validation activities
  • Perform Audits internal & external
  • Annual Product Reviews
  • Recalls and/or notification of events to regulatory agencies

Requirements

  • 2+ years' experience in a cGMP regulated manufacturing and packaging environment, with exhibited knowledge or proficiency in Quality Assurance and Compliance.
  • Ability to speak, present data, and defend approaches in front of audiences and inspectors.
  • Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
  • Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
  • Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

Fastnet - The Talent Group
'Not Just Placers.........Partners'

The Life Science Specialists

By using this website, you consent to the use of cookies in accordance with the privacy policy Ok, got it