Quality Systems Specialist, Galway
|Contact Name:||Larry O’Leary|
Our client, a Medtech company based in Galway now seek a Quality Systems Specialist to support the site CA/PA process as site mentor. As site mentor you will ensure the implementation, co-ordination and continuous review of the CAPA, Internal and Corporate Compliance programs.
The successful hire will act as an expert resource in external regulations and standard requirement knowledge for cross functional teams. Hence having the responsibility and authority to make decisions related to product quality, including the disposition of non-conforming product.
The ideal candidate will uses their knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality, particularly in minimizing customer complaints investigation for areas under their control.
Please note: this long term contract role with view to go permanent.
Responsibilities for Quality Systems Specialist:
Collect and analyze business/quality system process data from different parts of the company.
Report metric information as required (i.e. NCRB and Management review)
To provide assistance and support to cross functions on quality system requirements and supports site External Inspections.
Ongoing review and update the Quality System procedures.
Strong team member with the ability to identify and drive quality improvements, in product and process quality.
Oversee validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
Support new product/technology transfer to ensure compliance to all internal and regulatory requirements.
Work with supplier quality team, other technical functions within and outside of the site and customers should the need arise.
Requirements for Quality Systems Specialist:
Honours Bachelor’s Degree in Science, Engineering or similar technical discipline.
3 – 4 years’ experience in a cGMP environment, that is FDA regulated.
Strong experience in either participating or leading internal auditing process.
Proven knowledgeable and experience in Quality Systems role.
Please contact Larry on +353 1 2302400 / email@example.com / www.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.
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