Job Overview
We are seeking an experienced Pharmaceutical Quality Lead to join our team in Ireland. This is a fantastic opportunity to be part of a fast-paced project, with lots of opportunities to work with and learn about cutting-edge technologies, in addition to developing your own skills.
This project will contribute to the manufacturing of a life-changing treatment.
Key Responsibilities:
* Lead the Drug Product Intermediate and final Drug Product quality release activities;
* Ensure that the batch has been manufactured and tested in accordance with current GMP Guidelines Directive /94/EC, EC Guide to GMP for medicinal products and/or the FDA Code of Federal Regulations.
* Ensure that the batch is released according to the relevant Annex to the Rules and Guidance for Pharmaceutical Manufacturers and Distributors. In particular Annex 13 – Investigational Medicinal Products and Annex 16 – Certification by a Qualified Person and Batch Release.
* Work with the Specialist Quality Team to oversee Quality Management Systems and Quality Processes
Requirements:
* Qualified Person status achieved. Relevant working experience acting as Qualified Person named on a Manufacturing & Importation Authorisation (MIA) is desirable.
* Proven experience within the Pharmaceutical industry in a QA/QC/Compliance role.
* Excellent knowledge of regulations and sources of regulatory information.
* Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise, LIMS, QSAT).
* Knowledge and demonstrated expertise in Lean / Continuous Improvement.
* Experience in High potency manufacturing / continuous manufacturing / Spray drying / Laboratory GMP / Project Management is desirable.
* Degree or post-graduate qualification in Science, Pharmacy or equivalent.
About the Opportunity
This is a truly exciting project that offers a chance to work with a leading organization in the pharmaceutical industry. As a Pharmaceutical Quality Lead, you will have the opportunity to develop your skills and knowledge, and contribute to the manufacturing of a life-changing treatment.
This role is perfect for those who are passionate about quality and want to make a real difference in the industry. If you are looking for a challenging and rewarding role, please apply now.