Qualified Person - Pharmaceuticals - Ireland - 11-Month Contract
Do you want to be part of one of the top 10 best companies to work for in Ireland? If so, this could be your chance One of our global pharmaceutical clients is looking for a Qualified Person to join their team in their new multifunctional facility.
This is a fantastic opportunity to be part of a fast-paced, € million project; with lots of opportunities to work with and learn about cutting-edge technologies, in addition to developing your own skills.
This is a truly exciting project, which when complete will contribute to the manufacturing of a life changing treatment.
Responsibilities:
1. Lead the Drug Product Intermediate and final Drug Product quality release activities;
2. 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.
3. 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.
4. Work with the Specialist Quality Team to oversee Quality Management Systems and Quality Processes
Requirements:
5. Qualified Person status achieved. Relevant working experience acting as Qualified Person named on a Manufacturing & Importation Authorisation (MIA) is desirable.
6. Proven experience within the Pharmaceutical industry in a QA/QC/Compliance role.
7. Excellent knowledge of regulations and sources of regulatory information.
8. Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise, LIMS, QSAT).
9. Knowledge and demonstrated expertise in Lean / Continuous Improvement.
10. Experience in High potency manufacturing / continuous manufacturing / Spray drying / Laboratory GMP / Project Management is desirable.
11. Degree or post-graduate qualification in Science, Pharmacy or equivalent.
If this role is of interest to you, please apply now
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