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Interim Qualified Person ( QP )

Job Title

Interim Qualified Person ( QP )

Recruiter1st Executive
Industry SectorFMCG - Non Food, Manufacturing, Manufacturing - Other, Other, Pharmaceutical & Biotech
Salary£850 to £950 per day
Town/CityEast Riding of Yorkshire
LocationsHumberside & East Yorks, North Yorkshire, South Yorkshire, West Yorkshire, Yorkshire & Humber
Contract TypePermanent or Interim
Job CategoriesOperations, Supply Chain Jobs
Date Posted26 July 2017

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1st Executive are retained by a global FTSE100 Pharmaceutical organisation, who require a QP professional to join them on an interim contract / consultative basis. You require an exemplary QP background with excellent knowledge of the pharmaceutical and medical manufacturing sector, and associated EU regulations.

Principal Responsibilities:
  • To provide support for the organisation, in the capacity of the Qualified Person as defined in the Article 48 Directive 2001/83/EC in accordance with Directive 2001/83/EC, responsible in particular for carrying out the duties specified in the Article 51.
  • Ensure that all requirements as specified in the EU GMP Guide Part I Annex 16 are fulfilled

The individual may also be responsible for, but is not limited to:
  • Performing batch certification in accordance with requirements of EU Directives and GMP
  • Maintenance of the QP batch register
  • SOP review/approval
  • Reviewing and approving batch records, specification, deviations and change controls
  • Provide guidance on all non-conforming material/deviated batches.
  • Direct the investigation and determine the release disposition of such material/product
  • Reviewing the Annual Product Quality Reviews and Quality Agreements
  • Be able to lead the assessment and on-site audits of the third parties in order to appropriately control any outsourced activities
  • Support the Quality Assurance department for all compliance inspections of the site e.g. internal audits as well as Regulatory Inspections

Required Experience:
  • Eligible to undertake the duties of Qualified Person as defined in Article 51 of Directive 2001/83/EC
  • A relevant degree qualification (preferably in Chemistry, Pharmacy or Biological Science.)
  • Experience with FDA, MHRA, EMA and other regulatory agencies.
  • Experience in the auditing as a Lead Auditor.
  • Excellent communication skills.
  • Experience in release of sterile topical cream desirable

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Recruiter: 1st Executive
Tel: 0843 216 3030
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