Qualified Person (QP)/Quality Manager

Location: St Albans  |  Hertfordshire  |  England
Sector: Life Sciences
Consultant: Harvey Havell
Job Reference: HH/HQ506
Salary: £75000 - £80000
Job Status: Permanent / Full Time

Job Title:Qualified Person (QP)/Quality Assurance Manager

Reporting To:Managing Director

Location:St Albans

Salary:Up to £80K

JOB SUMMARY:

To be responsible for ensuring that all products are produced in accordance with the requirements of the appropriate Product Licences in full accordance with the guidelines for GMP as laid down in the EU directives and if satisfied to approve the release of the products in accordance with EU directive (2001/83/EU as amended).

JOB DUTIES:

  • To act as ‘Qualified Person’ in approving Finished Product for release onto the marketplace.
  • To act as Responsible Person as per requirements of the WDA(H) to ensure that the conditions of the licence are met and the guidelines of GDP are complied with.
  • To manage and supervise an adequate number of suitably qualified QC, QA and regulatory personnel and to ensure that a continuing programme of training is carried out.
  • To approve specifications, sampling instructions, test methods and QC procedures, including amendments.
  • To review and evaluate all completed manufacturing and packaging documents to ensure that each batch has been produced, tested and packed in accordance with the directives and the marketing authorisation.
  • To approve or reject starting materials, packaging components, intermediate bulk and finished products.
  • To approve and monitor suppliers of raw materials and packaging components.
  • To check and ensure that the QC laboratory and equipment is qualified and maintained to the required standards.
  • To ensure the establishment of the validation of all analytical methods.
  • To investigate in accordance with written procedures all complaints relating to the quality of the products and if substantiated to initiate action to prevent recurrence.
  • To liaise with the Quality Systems Manager on all aspects of Product Change and deviations from specification and the validation required before changes can be implemented.
  • To liaise with Quality Systems Manager to ensure that changes to the directives are incorporated into company policy and systems.
  • To liaise with the Qualified Person for Pharmacovigilance or deputy QPPV on any complaints and SPC updates relating to adverse effects and safety information.
  • To liaise and supervise regulatory department for variations / new manufacturing authorisations or other regulatory submissions.
  • To ensure that approval from the MHRA is obtained for all variations and amendments which alter either the Manufacturing or Product Licences.
  • To liaise with the MHRA and the Medicines Inspectorate to ensure that the Company conforms to the requirements of GMP and the Manufacturing and Product Licences.
  • To coordinate the preparation and hosting of MHRA and customer inspections.
  • To instigate and participate in “self-inspections”.
  • To participate in external audits of contractor manufacturers and suppliers.
  • To refuse to sanction any action that might adversely affect the quality of any products on site and to keep the Directors informed of any problems relating to the quality of the Company’s products.
  • To manage and coordinate the artwork system.
  • To represent quality in all site projects.

If this is of interest to you, please click the apply now button.

For more infortmation, call and ask for Harvey in the Life Sciences team.