Job Title: Quality Systems Specialist
We are seeking a highly skilled and motivated individual to join our innovative pharmaceutical company in Cork. This is an exciting 12-month contract opportunity for the right person.
The successful candidate 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:
* Responsible for Investigations, change controls, and document management.
* Supporting the digitalization and automation of quality systems to drive data insights, technology, and process innovation.
* Working knowledge of cGMPs and prior experience working in HPRA/FDA regulated facilities.
* Providing support, direction, and training to all departments in respect of specific quality system elements to ensure business, quality, and compliance goals are met.
* Assesses compliance systems on an ongoing basis to identify opportunities for process improvement.
Education Requirements:
* Experience with tools such as Tableau, Spotfire, Google Analytics, Rapid Minor, or Python, and intermediate/advanced Excel skills will be a distinct advantage.
* Minimum of 3-5 years' experience within the biological and/or pharmaceutical/medical device industry.
* Knowledge and application of industry regulations as they apply to systems including those of FDA, HPRA, EMEA, and other authorities.
Please note that Morgan McKinley is acting as an Employment Agency, and references to pay rates are indicative.
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