Job Opportunity
We are seeking a qualified professional to maintain and develop quality standards for product lines at our pharma manufacturing site.
About the Role
1. Ensure an effective pharmaceutical Quality Management system is in place, meeting regulatory requirements.
2. Be responsible for the disposition of medicinal products.
3. Manage communications with regulatory authorities and represent the company during inspections.
4. Support inspections and prepare written responses.
5. Oversee team reviews and approvals of Non-Conformances, CAPA, change controls, and complaints.
6. Verify batch records comply with GMP and Market Authorization before release.
Requirements
* A minimum of one year's experience in GMP sterile manufacturing.
* A relevant third-level qualification in science or equivalent.
* The candidate must be eligible to act as a European Qualified Person (QP), certifying products in compliance with 91/412/EEC and EU2019/6 & Annex 16.
* Primarily an onsite role with some flexibility.