Job Title: Qualified Person
We are recruiting for a talented individual to join our Quality Assurance team at an award-winning pharmaceutical organization in Waterford.
About the Role
This is an exciting opportunity for anyone looking to work with a leading multinational company that consistently pushes the boundaries of innovation in medicine.
Our team is comprised of QPs, Managers, Technical Leads, Team Leads, and Quality Specialists who are dedicated to transforming the practice of medicine by turning the impossible into possible.
About Us
We provide life-changing treatment options to millions of people globally.
As part of our team, you will have the opportunity to work in a state-of-the-art sterile filling facility.
We produce both commercial and clinical products, with a robust pipeline that drives our business forward.
Main Responsibilities
* Ensure licensed product certification and release to market in accordance with EU directives and regulatory requirements.
* Manage batch disposition processes to ensure timely product release while maintaining compliance with site practices and regulations.
* Support major investigations, ensuring all product deviations are closed prior to batch release.
* Participate in cross-functional teams as a Quality/Qualified Person representative.
Requirements
* Advanced degree; preference given to candidates with eight or more years of cGMP experience acting as Qualified Person, named on the Manufacturer's/Importer's Authorisation (MIA).
* Proven leadership skills comparable to 2+ years of management responsibility.
* Post Graduate Qualification required (MSc or equivalent).
* Biologics manufacturing experience highly desirable.
* Experience in Sterile Manufacturing and/or Clinical Trials Regulations highly desirable.