QPLocation Cork, Ireland Apply
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The Qualified Person (QP) is responsible for fulfilling QP responsibilities in relation to batch release of commercial (product for sale or supply in the EU or for export) and clinical product, in accordance with the requirements of EC/2001/83, EC2001/20 and Annex 16 and 13 requirements, as applicable
This includes release of Products that are manufactured at BioMarin facilities and/ or Contract Manufacturing Organisations.
The Qualified Person (QP) is responsible for ensuring that, prior to the certification of any given batch of formulated bulk drug substance, drug product and finished goods, each batch has been manufactured and tested in accordance with the requirements of its Marketing Authorization or Product Specification file and the principles of current Good Manufacturing Practice (cGMP) prior to final release of the batch.
- The QP is responsible for the Quality oversight of contract manufacturers, testing and for leading, monitoring and supporting the quality performance of quality systems according to GMP standards
- The QP will take part in Material Review Boards, CMO Quality Reviews, Supply planning and Product Governance Meetings.
- The QP will be involved in product complaint investigations, quality defect investigations and for deciding the measures to be taken to manage any potential risks presented by these issues including recalls.
- The QP will partner with departments across BioMarin and with CMO’s providing Quality Oversight of CMO’s.
- The QP will support major investigations and deviations
- The QP will review and approve Product Quality Reviews
- QP Qualification, with at least 8 years of experience, in an EU licensed facility in a relevant functional area.
- Qualified Person status achieved with min 3-5 years of relevant work experience acting as Qualified Person, named on a Manufacturing and Importation Authorisation (MIA)/ IMP (MA)
- Aseptic / Sterile Drug Product manufacturing experience essential
- Experience with IMP's (Investigational Medicinal Products) desirable
- Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
- Understanding and familiarity with European/ FDA regulatory requirements, guidelines, and expectations.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Maintain knowledge up to date with respect to the current Good Manufacturing Practices (cGMP), technologies and quality systems for the products they certify.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.