QP-Qualified Person Job -Westmeath
Excellent opportunity for a QP- Qualified Person to join a leading biopharm company in Ireland.
I am delighted to be assisting this leading pharma company. They have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun along the way . They are a global organisation but with a local feel, the company invests in the health and well-being of their employees by offering a superb benefits/well -being package together with a flexible working culture
As the QP- Qualified Person you will oversee 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.
Key responsibilities of the Qualified Person job:
- 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 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.
- Bachelor's degree /MSc.
- Experience ,knowledge, skills, and abilities to perform the job
- 5 years' experience or equivalent combination of education, training, & experience.
- Completed QP qualification and be eligible for QP status in EMEA.
- Experience in biologics manufacturing would be advantageous
For more information please contact Felicity 086 7821714 or apply with up to date CV (Word)
Keywords: QP/Qualified person Job Ireland , GMP, pharma, biopharm, Qualified Person (QP) Job Ireland.