Job Description
Our client, a multinational company based in Galway now see a Quality Assurance Specialist to perform a variety of QA review / approval functions and provide quality assurance for the incoming, commercial and stability batch testing in Analytical labs.
The successful candidate will ensure QA compliance of the Analytical Lab and Product Release areas to ensure compliance to internal procedures and external regulatory standards
This is an initial 12 month contract role which should progress to a long-term / permanent role.
Responsibilities of QA Specialist, Analytical :
Provides quality assurance support and direction to the analytical laboratory responsible for the testing and release of all drug combination products and raw materials used on the site.
Responsible for ensuring that Raw Materials, Finished Goods, non-routine and Stability testing is carried out in accordance with cGMP both in company laboratories and at the contract laboratories.
The QA Specialist shall provide support and guidance in the areas of cGMP, Compliance, Regulatory, and Technical Investigation.
The role also requires working with the cross functional groups including Product Release, Supply Chain Planning, Shipping and Distribution groups.
Requirements of QA Specialist, Analytical:
Bachelor's Degree in Science, Engineering or similar technical Degree qualification.
3+ year's Analytical Chemistry and QA experience in FDA regulated environment.
Proven experience in running investigations in quality issues in laboratory.
Experienced with electronic (CDS, LIMS, SDMS, etc.) systems.
Experienced in data trending as quality indicator.
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. www.rftgroup.ie
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Key words; Quality Management, Quality Assurance, Analytical Laboratory, Quality Systems, Product Development, QC Testing, Product Release, New Product Introduction, Medical Devices, Pharmaceutical, Galway, Clare, Connaught.