Job Description
Our client, a medtech manufacturer based in Galway, now seeks a Quality Validation Specialist who will manage new product introduction (NPI) activities, and associated validations activities as part of an overall project team.
The successful candidate will partner with R&D in sister sites and internal stakeholders to ensure that the transition of products into manufacturing is smooth, timely and cost effective.
This is a fixed term contract role.
Requirements for Quality Validation Specialist:
Bachelor's Degree in Engineering, Science or Quality Assurance or similar technical discipline.
3+ years' NPI experience in a similar Quality or Validation role, in regulated industry
Detailed knowledge of the regulatory environment, i.e. FDA, cGMP, ISO13485, etc.
Proven experienced with CAPA, deviations and leading investigations.
Experience in conducting audits and dealing with regulatory bodies.
Project management experience is desirable.
Please contact Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. For a list of all our current vacancies, view our website http://www.rftgroup.ie/
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Key words: QA, Validation Engineer Quality Specialist, Quality Engineer, Validation, NPI, Quality Management, Process Validation, Tech Transfer, Auditing, Galway, Athlone, Roscommon, Medical Devices, Pharmaceutical.