Harrow, UK
Posted by: Karolina Madejska
14 Nov
13 Jan expires

Qualified Person

Harrow, UK
Job Description

*Job Description
• Responsible for QP certification and release of batches of subject doses assembled, in compliance with GMP and regulatory requirement
• Responsible for Quality Control ensuring that viable and non-viable environmental monitoring results comply with design specifications and primarily packaging materials are approved /released before use.
• Responsible for setting up IMP Terms of Supply as required
• Ensuring documentation of the receipt, storage, preparation, drug accountability of investigational medicinal product (IMP) are in accordance with to cGCP and EU GMP guidelines
• Provision of guidance/ input into set up of assembly activities and design of worksheets/ documentation and procedures for assembly of IMPs as required.
• Participation in investigation of quality issues/ deviations arising from assembly activities or facility (IMP assembly/ and storage areas)
• Other duties as required


Job ID Reference
Desired Skills & Experience

*Job Qualifications
• Pharmacy, Biological or Chemical Science degree
• Eligible to act as an MIA (IMP) QP and be named on MIA (IMP) Licence
• Member of a recognised regulatory body (such as The Royal Pharmaceutical Society of Great Britain, The Institute of Biology or The Royal Society of Chemistry)

  Harrow, UK
 Harrow, UK