- JN -032023-1927037
- Mar 10, 2023
- €25 - €30 ph
Are you a Quality Systems Specialist that wants to work with a sense of security, fulfilment, and purpose? If so this could be the opportunity for you.
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.
Responsible for Investigations, change controls and doc management.
Supporting the digitalization and automating of quality systems to drive data insights, technology, and process innovation.
Working knowledge of cGMPs and prior experience of working in HPRA/FDA regulated facility.
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 ongoing basis to identify opportunities for process improvement.
Experience with tools such as Tableau, Spotfire, Google Analytics, Rapid Minor, or Python, and intermediate/advanced Excel 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.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.