Qualified Person - Pharmaceuticals
This is a unique opportunity to join one of the top pharmaceutical companies in Ireland as a Qualified Person.
You will be part of a fast-paced project, working with cutting-edge technologies and developing your skills.
This project has the potential to contribute to the manufacturing of a life-changing treatment.
Key Responsibilities:
* Lead the Drug Product Intermediate and final Drug Product quality release activities;
* Ensure compliance with current GMP Guidelines Directive /94/EC, EC Guide to GMP for medicinal products and/or the FDA Code of Federal Regulations.
* Release batches according to relevant Annexes, including Annex 13 – Investigational Medicinal Products and Annex 16 – Certification by a Qualified Person and Batch Release.
* Collaborate with the Specialist Quality Team to oversee Quality Management Systems and Quality Processes.
Requirements:
* Achieved Qualified Person status, with relevant working experience acting as Qualified Person named on a Manufacturing & Importation Authorisation (MIA).
* 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).
* 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.