Qualified Person (QP)

Qualified Person (QP)
  • £50,000 - £75,000 per Annum
    ANNUM
  • Permanent
  • Wiltshire, England, UK Wiltshire UK SN5 8YW
Job Ref: J36578
Sector: Science
Sub-sector: Pharmaceuticals
Date Added: 24 June 2020
Qualified Person (QP) Permanent Wiltshire - willing to travel to different sites in the UK Attractive salalry and package

Qualified Person (QP)

Permanent

Wiltshire - willing to travel to different sites in the UK

Attractive salalry and package

Are you an Qualified Person (QP) that has experience of working with variety of Pharmaceutical dosage forms?

This is a fantastic opportunity for an experienced QP to develop into a Associate Director level in the furture.

The role:

  • Undertake the duties of a Qualified Person as defined in Directive 2001/82/EC or 2001/83/EC.
  • Responsibility and performance of Batch Certification and Release of drug product in accordance with requirements of EU Directives and GMP.
  • Ensure each batch of medicinal products to which the manufacturer license meets 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.

Requirements:

  • Eligible to undertake the duties of Qualified Person as defined in Article 51 of Directive 2001/83/EC or Article 55 of Directive 2001/82/EC.
  • A relevant degree qualification (preferably in Chemistry, Pharmacy or Biological Science.)
  • Commercial experience with FDA, MHRA, EMA and other regulatory certified bodies.
  • Strong previous Quality Assurance/QMS experience.
  • Excellent communication and leadership skills.
  • Previous management and supervisory experience.

If you are interested in this opportunity and meet the above requirements please apply online, for further information contact Bal on 0121 728 8455.

SRGTalent
24/07/2020 18:12:26
GBP 50000 50000
Contact Consultant:
Balbir Panesar

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