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Qualified Person (QP)

Qualified Person (QP)

Job Title: Qualified Person (QP)
Contract Type: Contract
Location: Manchester, Greater Manchester
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: QP01_1493019422
Contact Name: Alex Young
Contact Email: a.young@sciproglobal.com
Job Published: April 24, 2017 08:37

Job Description

Our client is a manufacturer of Advanced Therapy Medicinal Products, specifically for autologous parenteral administration. Manufacturing operations are licensed by the Medicines and Healthcare Products Regulatory Agency under a Manufacturing and Import Authorisation (MIA) covering manufacture of unlicensed "special" medicinal products, and a Manufacturing and Import Authorisation, Investigational Medicinal Products MIA(IMP) covering manufacture in support of authorised clinical trials.

Requirement - With respect to the manufacture of investigational medicinal products, our client are required to provide the services of a "Qualified Person (QP") as described in article 13, clause 2 of the European clinical trials directive 2001/20/EC as amended. This person, when nominated on the MIA(IMP,) will be required to certify that autologous manufactured on site are compliant with National Law, Good Manufacturing Practises and the Clinical Trial Authorisation.

The current Quality Manager is eligible, under the permanent provisions of the EU directives, and nominated as Qualified Person. However, cover is required for sickness absence and annual leave. For this reason, they are seeking to retain the services of a Qualified Person to cover periods when the Quality Manager is not available. This QP is likely to be already operating as a contractor and will have the following competencies;

  • Eligible for nomination as Qualified Person on clinical and commercial manufacturing authorisations
  • A Minimum of two years as a qualified QP
  • Have at least 5 years' experience in the manufacture of sterile products
  • Have at least 5 years' experience in aseptic processing
  • Experience in the manufacture of Advanced Therapy Medicinal Products

In order that the legal and professional obligations incumbent on the Qualified Person are met the following operational mode is proposed;

  • Attendance to site as part of Quarterly Quality Meetings
  • Provision, review and feedback of meeting minutes from monthly Quality Meetings
  • General oversight of the Quality Management System/Self Inspection/Auditing
  • A minimum of one day audit per year as part of the self-inspection program or independently
  • Where possible at least one month advanced notice of requirements for product certification
  • Two days on-site time to cover batch certification activities as agreed
  • Further oversight requirements can be discussed and agreed

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