Qualified Person Opportunity
This is a chance to take on a key role in the pharmaceutical industry, contributing to the manufacturing of life-changing treatments. As a Qualified Person, you will be responsible for leading the quality release activities of drug products and ensuring compliance with current Good Manufacturing Practice (GMP) guidelines.
This is an exciting project that offers opportunities to work with cutting-edge technologies and develop your skills. You will be part of a fast-paced team, working towards a common goal of producing high-quality medicinal products.
Responsibilities:
1. Lead Drug Product Intermediate and final Drug Product quality release activities;
2. Evaluate batch production and testing against GMP guidelines and regulations;
3. Ensure batch release according to relevant Annex to Rules and Guidance for Pharmaceutical Manufacturers and Distributors;
4. Work with the Specialist Quality Team to oversee Quality Management Systems and Quality Processes;
Requirements:
5. Achieved Qualified Person status.
6. Relevant working experience acting as Qualified Person named on a Manufacturing & Importation Authorisation (MIA).
7. Proven experience within the Pharmaceutical industry in a QA/QC/Compliance role.
8. Excellent knowledge of regulations and sources of regulatory information.
9. Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise, LIMS, QSAT).
10. Demonstrated expertise in Lean / Continuous Improvement.
11. Experience in High potency manufacturing / continuous manufacturing / Spray drying / Laboratory GMP / Project Management desirable.
12. Degree or post-graduate qualification in Science, Pharmacy or equivalent.
This is an excellent opportunity for those seeking a challenging role in a dynamic environment. If you are a motivated individual with a passion for quality assurance, this could be the perfect fit for you.