Hobson Prior are looking for a Qualified Person to strengthen the European Regulatory Affairs department at a leading biopharmaceutical company on a contract, part-time basis.
Act as a Qualified Person in relation to MIA 39 according to GMP/GDP regulations, local laws and company procedures.
Carry out the Routine Duties of a Qualified Person as defined in MHRA Guidance on Manufacture and Importation.
Ensure Marketing and Manufacturing Authorisation requirements are met for batches to be certified.
Ensure GMP/GDP requirements are met.
Ensure principal manufacturing and packing processes have been validated.
Review of batch documentation and testing results for release to ensure compliance with release specification.
Review of change controls to ensure appropriate status for batch release.
Ensure all sampling and testing has been carried out as appropriate.
Make sure all batch documentation is suitably reviewed to ensure completeness.
Continually maintain suitable knowledge.
Ensure that a log is maintained for all batches certified.
Ensure suitable reference/retention samples are kept for the appropriate period in an appropriate location.
Take part in internal audits or external audits as requested or as appropriate.
Review and/or approve GxP documentation.
Undertake project work as directed by the Quality Lead.
Good interpersonal and communication skills.
Current knowledge of requirements for GMP and GDP.
10 years' experience in the pharmaceutical industry.
Eligibility as Qualified Person (UK)
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.