Quality Systems Associate

  • Cork
  • Temporary 12 months
  • JO-1904-64388_1557824839

Summary

Responsibilities:

  • Deviations, Change Controls and CAPA's
  • Document Control
  • Internal Audit
  • Inspection Readiness
  • Annual Product Review
  • SQRT
  • Site Master File
  • Oversee relevant metrics and trending for each quality system and take action to drive the correct behaviours.
  • Manage the preparation and facilitation of Corporate & Regulatory Inspections.
  • Use science and risk-based methods to increase Quality Culture throughout the facility.
  • Provide Root Cause Analysis support for the site
  • Maintaining the core Quality Systems, and providing training on the core Quality Systems
  • Leading internal audits for the site
  • Development and Trending of Quality metrics for the site to ensure continuous improvement of Quality Systems and Manufacturing processes
  • Liaise with colleagues to aid in harmonization of Global Quality functions and systems
  • Drive projects to improve Quality Systems across site
  • Liaise with Regulatory department to support GMP filings as required

Requirements:

  • B.S. with at least 5 years of experience in a relevant functional area.
  • 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.

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