Qualified Person

Job Ref: J20893
Sector: Science
Sub-sectors: Biotech/Life Sciences, Pharmaceuticals
Date Added: 31 March 2017

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QUALIFIED PERSON (QP)

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 CompanyMaintain 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.

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.