QP - 12 months FTC

Employer
Location
UK, Liverpool
Posted
Sep 19, 2016
Closes
Oct 17, 2016
Ref
5000140783310
Discipline
Clinical, Quality
Result Type
Jobs
Position Type
Permanent
Hours
Full Time

AstraZeneca Supply Biologics (Previously MedImmune Speke) is the global center of excellence for Influenza live attenuated vaccine production. Our highly specialized Quality team are essential to the safe and successful manufacture of over 15 million Inflenza vaccines per annum. With our recent launch into the EU market the site continues to grow and expansion of the Quality team is integral to this.

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:

  • Fulfils 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
  • Ensures 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
  • Manages on time QA releaseof Master Virus Seed, Monovalent Bulk and Fluenz drug product
  • Acts a primary QP for Fluenz regarding communication with EU OMCL for EU release and QP's in EU distribution
  • Performs QP oversight of drug substance and drug product manufacturer's internally (PA, CA, KY) and externally (licensed Outside Testing Laboratories).


Responsibilities: Batch Review and Release/Certification

  • Reviews 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'
  • Liaison with the UK authorities for licenses and certificates as required by Corporate Regulatory Affairs
  • Supports Batch Management Notification to sr. management
  • Performs the release according to Supply Chain schedule
  • Reviews and approves as EU-QP
    • 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
    • Temporary change requests for validated systems
    • 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
    • All batch related Quality Risk Assessments (Annex 20)
  • Authorizes 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)
  • Acts as a QA Subject Matter Expert (SME) with respect to non-conformances from OTLand QC laboratory
  • Represents Quality Organisation as QP
  • Cooperates with other Medi QP's with respect to alignment of Quality System e.g. Release Management, Change management, SAP release
  • Reviews and approves 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)
  • Reviews and approves Product Market Corrections and Recalls (within the EU)

Requirements / Qualifications/ Competencies

Education

  • Graduate or higher degree (to Ph.D) in biological sciences
  • The incumbent is certified as a EU Qualified Person on a EU licensed manufacture of
    (bio)pharmaceuticals

Experience

  • Demonstrate a sustained period as a QP on a 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)
  • Demonstrable experience as an established Leader in (bio)pharmaceutical Industry.
  • Membership of a professional body e.g. ISPE, PDA, IOB, RSC or QP forum
*LI-MEDI *NS-MEDI . Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation