Are you a skilled professional seeking a challenging opportunity in the pharmaceutical sector? We have an exciting role for a Qualified Person to join our team at a new multifunctional facility in Ireland.
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 Good Manufacturing Practices (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;