Quality Systems Specialist-Limerick

3 weeks ago

Limerick, Limerick, Ireland TN Ireland Full time

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Quality Systems Specialist-Limerick, LimerickClient:

Morgan McKinley

Location:

Limerick, Ireland

Job Category:

Other

EU work permit required:

Yes

Job Reference:

993de82ab46b

Job Views:

3

Posted:

19.04.2025

Expiry Date:

03.06.2025

Job Description:

Job Description

I am recruiting on behalf of an innovative pharmaceutical company in Cork who has an amazing opportunity for the right person. This is initially a 12-month contract position.

As the Quality Systems Specialist, you will be primarily responsible for establishing, developing, implementing, and maintaining quality systems processes and programs, including Product Documentation, Investigation Systems, Regulatory Inspections, Document Control, Change Management, Training, and Technical Document review.

Daily Activities:

  1. Responsible for Investigations, change controls and document management.
  2. Supporting the digitalization and automation of quality systems to drive data insights, technology, and process innovation.
  3. Working knowledge of cGMPs and prior experience of working in HPRA/FDA regulated facility.
  4. Providing support, direction, and training to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.
  5. Assessing compliance systems on an ongoing basis to identify opportunities for process improvement.

Education Requirements:

  1. Experience with tools such as Tableau, Spotfire, Google Analytics, Rapid Minor, or Python, and intermediate/advanced Excel will be a distinct advantage.
  2. Minimum of 3-5 years' experience within the biological and/or pharmaceutical/medical device industry.
  3. Knowledge and application of industry regulations as they apply to systems including those of FDA, HPRA, EMEA and other authorities.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

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