This role is an opportunity to expand to experience, you will be responsible for ensuring the on-going development and maintenance of the Quality Management System.
Continuing development, implementation and maintenance of the Quality Management SystemManagement of deviations, CAPA's and change control notifications associated with commercial products.
Operation and maintenance of quality documentation system
Preparation and delivery of training on QMS, SOP's and processes.
Developing and reporting quality metrics
Coordinating and leading a periodic review of the QMS and management review.
Participation in the preparation of annual reports, annual product reviews and core documents.
Vendor evaluation, audit and internal quality review
Education & Experience Requirements
The QA Specialist will have a BS degree and a minimum of 5 years experience in a quality role in a biotech or pharma company
Thorough understanding of quality management systems and GMP required
Experience participating in internal and external audits
It is essential the candidate is a multi-tasker comfortable working in a team-based environment.
Some travel may be involved including to the US and EU
For further information on this QA Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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