Qualified Person Role
A seasoned professional is sought to fill the position of Qualified Person in the Life Sciences industry. The opportunity offers a permanent full-time position with flexible working hours, autonomy, and trust.
* To fulfill the company's requirements regarding Qualified Person services, adhering to Annex 16 guidelines.
* To provide input for the development and implementation of the Quality Management System.
* To ensure compliance with Good Manufacturing Practice (GMP) regulations.
* To host regulatory agency inspections and customer audits.
* To support internal and external quality audits as required.
* To deliver training on GMP procedures as necessary.
Requirements
* A degree in a scientific discipline: Chemistry, Pharmacy, Pharmaceutical Chemistry, or Biology.
* A minimum of five years' experience in the pharmaceutical industry.
* Status as a Qualified Person, meeting the HPRAs educational requirements, experience, training, and licensing criteria.
* Residency and operation within the European Economic Area (EEA).
* Skills for managing quality functions, including ability to work cross-functionally.
Desirable Skills
* Experience with Investigational Medicinal Products (IMPs) in Europe, handling various scenarios.
* Background in sterile or biologics production.
This role presents an excellent opportunity for a qualified individual to make a significant impact in the Life Sciences industry. If you possess the necessary skills and qualifications, we encourage you to apply for this challenging and rewarding position.