**Job Title:** Qualified Person
We are seeking a highly experienced and qualified individual to join our team as a Qualified Person. As a leading biologics company in the West of Ireland, we are committed to maintaining the highest standards of quality and compliance in our commercial products.
**Key Responsibilities:**
1. Ensure that each commercial batch meets the required standards under Irish law, marketing authorization, and EU Good Manufacturing Practice (GMP) regulations.
2. Fulfill the responsibilities of a Qualified Person, including maintaining detailed knowledge of GMP principles and ensuring compliance with regulatory requirements.
3. Verify the integrity of our supply chain and quality systems throughout the product lifecycle, confirming that all manufacturing and testing sites comply with the relevant Marketing Authorization (MA).
4. Oversee audits of all sites, ensuring that reports are available prior to certification and that any issues are promptly addressed.
**Requirements:**
1. Eligibility as a Qualified Person under relevant regulations.
2. Experience as a named Qualified Person in a licensed facility is preferred.
3. Ideally, experience in sterile manufacturing or biotechnology would be beneficial.
4. Strong understanding of cGMP principles and their application in a commercial setting.
5. Excellent technical and compliance writing skills.
6. Preferably, experience in a managerial capacity.
7. Familiarity with regulatory inspections and GMP audits is essential.
As a Qualified Person at our company, you will play a critical role in ensuring the quality and integrity of our commercial products. If you have the necessary experience and qualifications, we encourage you to apply for this exciting opportunity.