Qualified Person - QP

On behalf of our client, a leading medical device & healthcare company, we are currently recruiting for a Qualified Person. Based in the Dublin location, this is a part time flexible opportunity.

Ensure that the quality system is implemented and maintained in such a way to ensure that all services provided to B Braun Customer’s meet both internal and external requirements, including EU Regulations and HPRA Guidelines for Good Manufacturing Practice (GMP), Corporate and Customer requirements.

Core Responsibilities/Authority:

· Ensure that the quality system is implemented and maintained.

· Ensure that the conditions of the Manufacturers/Importers Authorisation (MIA) are being complied with and that the GMP guidelines are being followed.

· Ensure that the quality, safety and traceability of MIA medicinal products are maintained within the supply chain.

· Ensure appropriate competence and experience as well as knowledge of and training in GMP.

· Ensure that items affecting the Safety, Identity, Strength, Purity, or Quality (SISPQ) of the Product are actioned appropriately.

· Fulfil responsibilities personally.

· Carry out their duties in such a way as to ensure that the MIA holder can demonstrate GMP compliance and that public service obligations are met.

To succeed in this role, we imagine that you have the following qualifications:

Minimum of BSc Degree or equivalent third level education

Qualified Person Status in accordance with EC Directives
Minimum 2 years, experience in quality or production function within the pharmaceutical industry

For a full Job Spec and to apply for this role please call Linda on 01 2784701 or e-mail [email protected]

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671

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