Quality Specialist GDP S011847

Job Title: Quality Specialist GDP

Salary: €Negotiable on experience

Location: Dublin/Midlands

Ref: S011847

Description of Role:

Our client is healthcare distributor supplying a range of medicines and products to hospitals nationwide. Due to expansion they are currently looking to add to their quality team and appoint a quality specialist who will also act as deputy RP.

Requirements:

5+ years QA experience in a HPRA/EU GDP regulated environment.

Thorough knowledge of temperature-controlled activities.

Thorough knowledge of Good Distribution Practice and global regulatory requirements in respect to the wholesaling of medicinal products.

Key Duties & Responsibilities:

• Assist in the development, implementation and maintenance of the Quality Management System.

• Ensure Good Distribution Practice and current Health Products Regulatory Authority (HPRA) guidelines are adhered to covering all GDP activities performed.

• Assist in ensuring the Quality processes are compliant and well understood across the business through continuous training, retraining and informative communications.

• Ensure that all staff are initially trained upon commencement of employment and that a continuous training program is in place for all current and new employees.

• Ensure that only the relevant authorised product classes are procured from approved suppliers and supplied to approved customers and are covered under the Company‘s WDA

• Assist in the approval of outsourced service providers and assist in route qualifications of transport providers as planned and required.

• Review, Draft and Implement documentation including change controls, deviations, validation documentation, SOP‘s etc.

• Act as deputy Responsible Person fulfil all the responsibilities and duties on behalf of the Responsible Person in their absence

For more information please send your CV to Hazel Whelan in confidence through the link.

Email Hazel@rplus.ie

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