We are delighted to be partnering with a global pharmaceutical company to support their search for a permanent Quality Manager & QP to join their Dublin team.
This company have a large product range with manufacturing facilities across the globe. This role sits within their Dublin site and has responsibility for the management and maintenance of the Quality Management System.
Furthermore, the job holder is acting as qualified person as per EU GMP and responsible person as per EU GDP requirements.
Responsibilities:
- Manage the QMS, ensure the QMS is fit for purpose, making changes as necessary approving SOPs and Quality System documents.
- Manage communications with and represent company in front of HPRA.
- Provide QA expertise and manage any Quality issues that arise to closure.
- Support HPRA inspections and prepare written responses to inspections.
- Provide QA oversight and expertise for New Product Introductions
- Review and approve Non-Conformances (NC), CAPA, change controls and complaints.
- Review, and where appropriate, preparation and regular update of technical agreements with licensees and 3rd party contractors
- Implementation of the Self Inspection/Internal Quality Audit program
Requirements:
- BSc (Hons) in Science or equivalent.
- QP/RP qualification.
- Thorough working knowledge of GMDPs and regulatory expectations for medicinal products and medical devices.
- Minimum of 5 years of experience working in Quality Assurance in the Health Care Industry.
This is a hybrid role, which would see you working 3 days in the office in West Dublin and 2 days from home.
