Life Changing Opportunity
This is an exciting opportunity to join a multifunctional facility in Ireland.
About the Role:
* You will play a key role in the manufacturing of life-changing treatments as a Qualified Person;
Your Responsibilities:
* Lead drug product intermediate and final quality release activities;
* Ensure batch manufacture and testing comply with Good Manufacturing Practice (GMP) guidelines;
* Release batch according to relevant regulations;
* Oversee quality management systems and processes;
The Ideal Candidate:
* You must have achieved Qualified Person status;
* Relevant working experience acting as Qualified Person named on a Manufacturing & Importation Authorisation (MIA);
* Proven experience in Pharmaceutical industry Quality Assurance/Quality Control/Compliance role;
* Excellent knowledge of regulations and sources of regulatory information;
* Knowledge of Quality IT systems desirable;
* Demonstrated expertise in Lean / Continuous Improvement;
* Experience in High potency manufacturing / continuous manufacturing desirable;
* A degree or post-graduate qualification in Science, Pharmacy or equivalent.