Qualified Person

Job Ref: J31726
Sector: Science
Sub-sectors: Biotech/Life Sciences, Pharmaceuticals, Medical Devices
Job Type: Permanent
Date Added: 11 October 2019
  • Scotland, UK UK FK9 4NF
  • Competitive
  • Emma Laurenson
  • 0141 847 0319
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SRG's client are looking for an experienced Qualified Person (QP) to join them at an exciting time for the business.This is a fantastic opportunity for an experienced QP.

The role:

  • Undertake the duties of a Qualified Person as defined in Directive 2001/83/EC.
  • Responsibility and performance of Batch Certification and Release of drug product in accordance with requirements of EU Directives and GMP.
  • Ensure products have been manufactured and tested in accordance with Good Manufacturing Practice as defined in EU Directive 2003/94/EC.
  • Ensure products manufactured demonstrate compliance with the requirements including EU GMP Annex 16 and also appropriate regulatory authorizations.
  • Working with the Quality Director and site management to ensure that GMP compliance implemented and maintained in accordance with the appropriate legislation, company policies/procedures and in compliance with appropriate manufacturing authorizations.
  • Review and implement Quality Management Systems in compliance with current GMP and any regulatory updates or observation.
  • Maintain product quality and release by enforcing quality assurance policies and procedures and GMP requirements.
  • Act as a Subject Matter Expert (SME) to facilitate site compliance with the company's Quality Management Systems.
  • Support the Quality Assurance department for all compliance inspections of the site e.g. internal audits as well as Regulatory Inspections.
  • Perform external audits
  • Support the self-inspection schedule for the Company
  • Maintain knowledge of current guidelines and regulatory advancement in line with the role for continued professional development.

The person:

  • 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.
  • Previous Quality Assurance experience
  • Excellent communication and leadership skills
  • Previous management and supervisory experience

If you meet the above requirements and think this sounds like an interesting opportunity, please apply online or contact Emma.

10/11/2019 10:23:38