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Quality Executive

Ref: 78661

  • 30,000-35,000
  • 17 Feb 2023
  • Tipperary
  • Permanent

Quality Assurance - In Process QA

About the Company

This is an exciting opportunity to join an expanding Life Sciences site in Tipperary and become a key member of the Operations Quality Team.

About the Position

In this role you will provide Quality Support to Production activities including batch record review, in process checks, sampling, documentation review and audits to ensure batches are manufactured in compliance with regulatory requirements, company policy and procedures.

Key Responsibilities

  • Support to batch manufacture including line sign-off prior to start of batch manufacture, performing in process checks during batch manufacture.
  • Perform routine review of documentation such as Batch records, logbooks, forms, protocols, reports, COAs, etc. generated to support commercial and development batches for accuracy, completeness, and compliance to GMP and procedural requirements.
  • Review of Standard Operation Procedures for manufacturing operations and cleaning.
  • Participate in any investigation related to manufacturing.
  • Prepare Standard Operating Procedures, investigations, reports and forms as required.
  • Perform swab sampling (bioburden and chemical)
  • Perform environmental monitoring
  • Perform internal / process audits.
  • Monitoring of GMP compliance during production activities
  • Review of unplanned work orders for production
  • Monitor documentation errors and work with personnel to correct documentation, as needed, and develop preventive actions to reduce or eliminate recurrences
  • Sampling and inspection activities.
  • Issuance of documentation for production – Batch Record, SOPs.


  • 2+ years Experience in Pharmaceutical GMP environment preferably with a company accredited with HPRA and FDA
  • Third level qualification in relevant area

Remuneration Package

For more information on the role or any other Engineering or Life Sciences roles call Nigel on 087 3618142 or email me or click the apply button below.

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