Job Title: Qualified Person
Purpose:
The Qualified Person is responsible for ensuring that licensed products are certified and released to market by a Qualified Person named on the commercial manufacturing license in accordance with EU directives 2001/83/EC, 2004/94/EC, and Annex 16.
Responsibilities:
* Manage the batch disposition process to ensure timely release of product.
* Ensure the batch disposition process maintains compliance with site practices & regulatory requirements.
* Support major investigations, ensuring all product deviations are closed prior to batch release.
* Participate in cross-functional teams as Quality/Qualified Person representative.
* Provide additional QP support to quality-related issues, as needed.
* Participate in internal committees/teams, as required.
* Provide advice and direction to other departments on quality issues.
* Ensure independence of the QP on decisions regarding quality-related matters.
* Build partnerships across the business to create a culture demonstrating excellence in quality, compliance, and continuous improvements.
* Provide audit support, as required, for internal auditing programs and supplier audits.
* Maintain an up-to-date knowledge of pharmaceutical legislation and industry practice.
Qualifications:
* Advanced degrees; eight or more years of cGMP experience preferred, with relevant work experience acting as Qualified Person, named on the Manufacturer's/Importer's Authorization (MIA).
* Consideration will be given to other relevant experience and education.
* Proven leadership skills comparable to 2+ years of management responsibility.
* Postgraduate qualification required (MSc or equivalent).
* Biologics manufacturing experience highly desirable.