Job Title: Qualified Person (QP)
The Role
We are seeking a Qualified Person (QP) to maintain and develop quality and regulatory standards for all product lines at our client's Kerry-based pharma manufacturing site.
Key Responsibilities:
* Maintain an effective pharmaceutical Quality Management system
* Fulfill all regulatory obligations of manufacturing
* Manage communications with regulatory bodies and represent the company during inspections
* Support regulatory inspections and prepare written responses
* Oversee the team in reviewing and approving Non-Conformances, CAPA, change controls, and complaints
* Evaluate batch records to ensure compliance with GMP and market authorization prior to batch release
Requirements
To be successful in this role, you will require:
* A minimum of one year's experience in GMP sterile manufacturing
* A relevant third-level qualification in science or equivalent
* Eligibility to act as a European Qualified Person (QP), certifying products in compliance with EU regulations
This is primarily an on-site role with some flexibility. If you are a motivated and experienced QP looking for a new challenge, please apply today.