Qualified Person - 12-months - Ireland
One of the top 10 best companies to work in Ireland is looking for a Qualified Person for their large-scale new facility in Ireland. Is this you?
An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.
What You'll Do
* Review and approve QA/QP procedures, training materials, and Quality Agreements.
* Support start-up activities, including Manufacturer/Importation Authorisation submissions and knowledge transfer.
* Perform QP release of Investigational Medicinal Products (IMPs) in line with regulatory requirements.
* Provide guidance during Health Authority GMP/GDP inspections and audits.
* Advise stakeholders on quality issue management and process improvements.
* Maintain Site Master File and oversee Manufacturer/Importation Authorisation updates.
* Ensure rapid communication of significant quality issues to senior management.
* Review and approve procedural documents and participate in cross-functional teams.
* Influence external regulatory environment through interactions with authorities and industry groups.
* Identify risk areas and contribute to global audit planning.
* Supervise QA personnel and champion continuous improvement initiatives.
What You'll Need
* Degree in science, engineering, or related discipline.
* Extensive experience in biopharmaceutical/pharmaceutical industry quality roles.
* Eligibility to act as EU Qualified Person under Manufacturing/Importation Authorisation.
* Experience with QP release of IMPs (preferred) and Responsible Person on WDA (desirable).
* Strong knowledge of ICH/GMP, data integrity, regulatory guidelines, and clinical supply chain processes.
* Proven leadership and influence management skills in a global matrix environment.
* Excellent communication and stakeholder engagement skills.
* Commitment to fostering a culture of continuous improvement and compliance.
*If this role is of interest, please apply now*