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Qualified Person

2 months ago

Edinburgh, United Kingdom SRG Full time

SRG's client are looking for an experienced Qualified Person (QP) to join them at an exciting time for the business as they continue to expand.


This is a fantastic opportunity for an experienced QP to take on a permanent role with excellent salary and benefits.


The role:

  • Undertake the duties of a Qualified Person as defined in Directive 2001/83/EC and Directive 2001/82/EC.
  • Influence the quality agenda and support the maintenance of the QMS to ensure it complies with all relevant legislative requirements.
  • You will be expected to provide a QP function for licenced ATMPs according to the relevant directives and guidelines.
  • You will conduct QP review of executed batch manufacturing records and certify as defined under SI2012/1916 and under the terms of the Company’s MIA and MIA(IMP) and relevant regulatory filings (MA, IND, IMPD as applicable).
  • Support the process of batch review and release and coordinate with Quality peers performing batch review duties as necessary.
  • Working with the Head of Quality and fellow QPs 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.
  • Maintain knowledge of current guidelines and regulatory advancement in line with the role for continued professional development.
  • Write, review, approve and maintain Quality SOPs applicable to key areas of the PQS as required.


The person:

  • Eligible to undertake the duties of Qualified Person as defined in Directive 2001/83/EC and Directive 2001/82/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
  • Prior experience in a pharmaceutical manufacturing environment
  • Excellent communication and leadership skills