My client, a global CRO company in Co. Westmeath, is recruiting for a Qualified Person to join their team. This is a full time permanent position and there is an option of working on site or working remotely!
The role of a Qualified Person is to oversees all functions related to the release of pharmaceutical medicinal product with requirements of Directive 2003/94/EC (Human) and investigational medicinal product, placebo or comparator (if applicable) for a defined clinical study upon importation or re-labelling, in accordance with the requirements of Directive 2001/20/EC and Clinical Trial Regulation (EU) 536/2014.
· Certifies batches prior to release ensuring that specific and detailed requirements and regulations have been met including the principles and guidelines of GMP as stated in Directive 2003/94/EC and the general conditions on the Manufacturer's License or Manufacturing Authorization (issued by the Irish Medicines Board) are followed.
· Maintains up-to-date knowledge and experience in the light of technical and scientific progress and changes in quality management relevant to the products which they are required to certify.
· Ensures that Quality Assurance Technical Agreements are set up with the Trial Sponsor.
· Performs GMP facility audits involved in the manufacturing of medicinal products used in the clinical study.
· Communicates with Project Management, Clinical Supply, Regulatory and Clinical functions internally as well as with the Trial Sponsor.
· Sets up and maintains Product Specification Files (PSF) for the medicinal products to be released for a clinical study as well as a register or all released batches.
· Develops and improves procedures related to the QP release process.
Qualifications - External
Experience and Qualifications:
· Bachelor's degree and Master’s degree or equivalent with relevant formal academic / vocational qualification.
· Suitable experience that provides the knowledge, skills, and abilities to perform the job
· 5+ years’ or equivalent combination of education, training, & experience.
· Completed QP qualification and be eligible for QP status in EMEA.
· Experience in biologics manufacturing would be distinct advantage.
As well as being rewarded a competitive salary, they have an extensive benefits package based around the health and well-being of their employees.
For a full Job Spec and to apply for this role please call Zoe on +353 1 2784671 or e-mail email@example.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671