Job Reference: frs42772
Job Duration:
Start date: 07/12/21
Description:
Excellent opportunity for a QP- Qualified Person to join a leadingbiopharm company in Ireland.(Perm job)
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 funalong the way . They are a global organisation but with a local feel, the company invests in the health and well-being of theiremployees by offering a superb benefits/well -being package together with a flexible working culture
I am delighted to be assisting them with the recruitment of a QP-Qualified Person
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 accordancewith the requirements of Directive 2001/20/EC and Clinical Trial Regulation (EU) 536/2014.
KEY DUTIES AND RESPONSIBILITIES:Your duties as the Qualified Person will be varied however the key duties and responsibilities are as follows:
* 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 inlight 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 facilityaudits 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.
ROLE REQUIREMENTS:
To be successful asthe Qualified Person / QP we must identify the following on application:
* 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 beadvantageous
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.
Industry: Pharmaceuticals
Salary: Pension, Health Ins, Bonus,Life Ass
Salary Benefits: Pension, Health Ins, Bonus,Life Ass
Vacancy Type: Permanent
Job Skills: Qualified Person-QP, QP, Qualified Person
Contact Name: Felicity Farrell
Website: -
Direct Application URL: -