Qualified Person
This is what you will do:
The Qualified Person is responsible to ensure that licensed Finished Product is certified and released to market by a Qualified Person named on the commercial manufacturing license in accordance with EU directive 2001/83/EC, 2004/94/EC and in accordance with the requirements of Annex 16.
To ensure that investigational medicinal product (IMP) is certified and released to sponsor by a Qualified Person named on the IMP Manufacturing License in accordance with EU directive 2001 /20/EC and in accordance with the requirements of Annex 16 and Annex 13.
As qualified person, this function is required to ensure that practices at Alexion Pharma International Trading are in compliance with Directive 2003/94/EC and the Rules and Guidance for Pharmaceutical manufacturers and Distributors 2014. They should provide oversight of the site quality systems at Alexion’s facilities. The Qualified Person is responsible for oversight of manufacture and testing of the drug substance/product. This role is a key member of the local quality lead team and ensures effective interaction with other departments locations. In particular, this will involve partnering with major stakeholders such as Manufacturing, Engineering, Technical Services and QC to optimize patient supply.
You will be responsible for:
- QP release of Alexion products across the Alexion network to ensure commercial and clinical drug substance, drug product and finished products are certified in accordance with GMP and MA/IMPD to support patient supply for rare diseases.
- QP Partner with Drug Substance, Quality Control and Finished Product teams ensuring on time release.
- Ensure independence of the QP on decisions on quality related matters.
- Builds partnerships across the business to create a culture that demonstrates excellence in quality, compliance and continuous improvements.
- Acts as quality point of contact, providing guidance and feedback relating to quality assurance operations, approaches to deviation investigations and improvements to ensure robust and efficient quality performance.
- Provide sound QA support to manufacturing, engineering, utilities and material movement (including cold chain) for both clinical and commercial products.
- Provide leadership for deviation investigations, including root cause analysis, and corrective and preventive action (CAPAs) proposals and initiatives.
- Drive compliance to quality metrics while maintaining high quality standards and implements course corrections when metrics or quality deliverables are off track.
- Perform QP quality review and approval for Annual Product Quality Review.
- Creates a culture & environment for 'right first time' in focusing on principles of lean, visual management and building in efficiencies as necessary from a systematic and compliance perspective.
- Provide Quality oversight, input into quality documents e.g. QAGs, customer complaints as required.
- Support Regulatory Inspections for Health Authorities and Regulatory Bodies.
- Provide audit support as required for internal auditing program and supplier audits.
- Provide support to Regulatory for Regulatory submissions (IMPD, MAA) / QP declarations and License updates.
- Maintain an up-to -date knowledge of pharmaceutical legislation and industry practice.
You will need to have:
- Minimum 5+ years GMP related experience in biopharmaceutical / pharmaceuticals.
- Eligible and demonstrated ability to act as Qualified Person within EC/EEA.
- Minimum 3 years QA/QP experience.
- A candidate has attained an academic qualification at least equivalent to a level 8 primary course in a scientific discipline.
- Together with the primary qualification, satisfies the educational requirements as defined in EU Directives 2001/82/EC and 2001 /83 /EC
We would prefer for you to have:
Experience in one or more of the following:
- Strong technical process knowledge across drug substance and drug product manufacture.
- Extensive experience in quality oversight of validation of new equipment, new products and process changes.
- Extensive experience in Quality Management Systems and Risk Management.
- Excellent interpersonal skills are required, as is the ability to communicate
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
