Job Title
Quality Specialist GDP
Salary
€Negotiable on experience
Location
Dublin/Midlands
Reference
S011847
Description of Role
Our client is a 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 Responsible Person.
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, SOPs etc.
* Act as deputy Responsible Person fulfil all the responsibilities and duties on behalf of the Responsible Person in their absence.
Contact
Email: Hazel@rplus.ie
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