This is a rare opportunity to join one of Cork's leading bio-pharma companies on a permanent basis.
The QA Systems Associate will be part of a well established team who are responsible for maintaining and the continuous improvement of site quality systems, providing quality oversight of the facility. This position requires thorough knowledge and experience of EU & FDA GMP regulations as well as developed organisational, and project management skills.
As this is a systems based role the key responsibilities will be based in an office environment and are outlined below:
- Participate in activities related to core quality systems
- Deviations, Change Controls and CAPA's
- Document Control
- Lead Internal Audits, Inspection Readiness & Annual Product Review
- 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.
- Provide Root Cause Analysis support for the site
- Development and Trending of Quality metrics for the site to ensure continuous improvement of Quality Systems and Manufacturing processes
- Liaise with Regulatory department to support GMP filings as required
EDUCATION & EXPERIENCE
- BSc. with at least 5 years of experience in a relevant functional area.
- 5+ years' experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in Quality Assurance and Compliance.
- 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.
If you would count communication, teamwork and goal orientated as your key definers and if you would like to work in an organisation that recognises honesty, integrity, hard work and ambition then click the apply now button or reach out to Kellie by email email@example.com for further discussions.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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