Qualified Person

3 weeks ago


Newcastle upon Tyne, United Kingdom Entrust Resource Solutions Full time
Qualified Person (QP)
Pharmaceuticals GMP
NE England / London
  
Our NE based pharmaceutical client is actively looking for a Qualified Person to join their successful operations. The successful candidate will be responsible for performing final and legal sign-off of batch records for imported and repackaged pharmaceutical products.
  
This position can be based in either NE England or London but will require regular site visits to the NE facility on a weekly basis
  
Applicants must be eligible to act as a Qualified Person (articles 48-51, Directive 2001/83/EC, with previous operational QP experience.
  
Additional responsibilities will include :
Acting as GMP Subject Matter Expert for QMS site compliance
Maintaining QMS systems, leading by example to implement and coordinate updates accordingly.
Leading and coaching QA Team
Ensuring all activities are completed in line with GMP and GDP compliance and implementing CAPAs to manage and resolve any Quality issues
Leading by example on all Compliance and Quality matters
Completing both internal and external audits
Communicating with onsite and offsite technical staff and liaising with customers and contract QPs to support batch release activities   
Ideally candidates will have previous experience of supporting Generics (finished products) manufacture and have a strong QC / QA / GMP background supporting manufacturing, API, packaging, licensing, release, and post-market activities.
  
This is a permanent opportunity offering an attractive salary (depending on skills and experience)
  
Role : Permanent
Location : NE or London – with regular weekly site visits in NE England
Salary : Attractive (depending on skills and experience)
  
For further information or to apply please contact Martin Cove on (phone number removed) (url removed)
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