Qualified Person (QP) - 12 months FTC
Qualified Person (QP) - 12 months FTC
Salary: Competitive salary
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. At MedImmune our employees make up a diverse and modern workforce. Our culture is defined by a strong sense of collaboration. We believe in rewarding talent and performance, and pride ourselves on being a great place to work.
This position presents an exciting opportunity for an established Qualified Person (QP) to join a leading organization that will capitalize on your full range of skills while providing the opportunity to develop and enhance your expertise. This position is also an urgent requirement to cover a maternity leave. As a QP professional you will be responsible for the following:
- Fulfil the requirements and duties as defined under the provision of EU Directive 2001/83/EC and is registered as QP with one of the EU Regulatory Agencies
- Ensure as QP that batches of commercial Master Virus Seed, Monovalent Bulk, Finished Product Fluenz and IMP's (produced at UK-1 or imported into EU via UK-1 from outside the EU) are manufactured, tested, labelled and packed in compliance with marketing licenses (BLA or MAA) and compliant to cGMP and Corporate guidelines prior to the release and export to a third country or distribution to EU markets
- Manage on time QA release of Master Virus Seed, Monovalent Bulk and Fluenz drug product
- PerformQP oversight of drug substance and drug product manufacturer's internally (PA, CA, KY) and externally (licensed Outside Testing Laboratories).
Additional responsibilities include Reviewing manufacturing Batch Records, release documentation, QC test results (internal and external) and other pertinent quality documentation for Master Virus Seed, Monovalent Bulk, Fluenz Finished Product and IMPs'. You will also ask as a liaison with the UK authorities for licenses and certificates as required by Corporate Regulatory Affairs.
As a QP, you will also review and approve all batch related level 2 and 3 non-conformances, Validated System Change Requests (VSCR) and CAPA's for products, associated utilities, process equipment and facility. You will approve temporary change requests for validated systems. You will also approve cumulative assessment of non-conformances Regulatory submissions for completeness and accuracy and evaluation of any change to the UK-1 facility procedures that would affect the regulatory compliance
In addition, you will authorize as EU-QP the batch disposition by signing the certificate of conformance for commercial distribution (according to EU- GMP Annex 16) or clinical use (IMP, according EU-GMP Annex 13)
You will also review and approve as QP the Quality agreement(s) with internal customers (PA, CA, KY) and external OMCL, as part of the Quality Oversight and in support to the Batch certification by the EU QP (EU GMP-Annex 16)
- To be successful in this role, you will need to be educated to degree level in Biological sciences
- You will also be certified as a EU Qualified Person on a EU licensed manufacture of
- Demonstrate a sustained period as a QP on an EU license.
- Substantial level of experience in pharmaceutical industry. It is preference, besides QA expertise and experience, to have also experience in Manufacturing or Testing of biologics (rec. proteins, antibodies (MCA) or vaccines)
- Membership of a professional body e.g. ISPE, PDA, IOB, RSC or QP forum
Closing date: November 30th 2016
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.