Quality , Science, Pharmaceutical & Food

Qualified Person (QP)

  • Contract
  • Remote
  • Northern England
  • 41937292

PE Global is currently recruiting for a Qualified Person (QP) for a leading multi-national pharmaceutical client based in Runcorn. This role is 100% onsite – no WFH option available. 


This is an initial 6 month contract with strong possibility for extension or to move to permanent for the right candidate.

 
The purpose of the role is to perform final QP Batch Certification to ensure that all products released to market comply with the requirements of the Manufacturer’s Licence, Marketing Authorisations, ANDAs, Technical Agreements, CE certification, in accordance with EU, USA, or other requirements e.g. Russia, Brazil, Canada.


Role:

  • To ensure the principles and guidelines of cGMP have been met during manufacturing, packaging and testing operations.
  • To verify all batch related documentation is compliant with the requirements of the regulatory authorities.
  • To review and certify batches in line with business shipment schedules.
  • To ensure Product Licences (Marketing Authorisations), ANDAs, Manufacturer’s Licence, Technical Agreements, CE Certification requirements have been met to ensure compliance
  • To ensure planned changes or deviations are supported by appropriate sampling, inspection, testing and check to ensure compliance with the requirements of the regulatory authorities
  • To ensure planned changes or deviations in manufacturing or quality control have been notified in accordance with well-defined reporting system
  • To ensure that manufacturing and testing processes have been validated and all the necessary checks and tests have been performed.
  • To ensure appropriate audits, self-inspections and spot checks are carried out by experienced staff
  • Appropriate measures should be taken to ensure the process, testing and product are compliant with all licensed requirements
  • Planning, Organising and Controlling
  • Release batches as per business schedule, where possible.
  • Meet the requirement of the Key Result Areas, including ensuring that principle manufacturing and testing processes have been validated, that all necessary checks and tests have been performed and that any planned or unplanned changes in manufacturing or quality control have been notified before any product is released.


Requirements:

  • Minimum 2-3 years’ experience in similar role with batch certification and operational oversight of a manufacturing/supply site
  • Qualified to Degree level or equivalent in Science.
  • Membership of appropriate professional body.
  • Registration as a Qualified Person, with acceptability to the Licensing Authority
  • Significant experience in a senior Quality role with experience as a Quality Leader in a modern manufacturing environment within the pharmaceutical industry desirable.
  • Good communicator and team worker with the ability to set and deliver high performance standards relating to quality, safety, cost and customer service

Interested candidates should submit an updated CV.

Please click the link below to apply or alternatively send an up to date CV to Jennifer.horgan@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***

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