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Qualified Person

Job Description

Overview

Taylor Strategy Partners are retained to search for a Lead Qualified Person for a growing pharmaceutical company with a cutting-edge production site based in Devon. Our client is looking for a commercially focused Lead Qualified Person to support the organisation's growth plans and through effective leadership of the QP team as they move further towards becoming a dynamic contract manufacturing organisation. Reporting to the Quality and Technical Director, the successful candidate will lead the QP team, focusing on process improvements, KPI and objective setting as well as promoting effective cross functional communications across all relevant areas of the organisation. As an experienced Qualified Person, we are seeking a strong technical ability and a natural leader with strong relationship building / influencing skills and a commercial mindset.

Responsibilities

  • To lead the strategy and direction of the QP team
  • Lead and manage the QP/Release group, including other QPs, Trainee QPs, and other Releasing Officers
  • Provide a highly specialist service to ensure medicines are manufactured and the quality, safety and efficacy are risk assessed to ensure compliance with pharmaceutical legislation
  • Be the point of contact within the business to provide expert advice on the quality of medicines manufactured
  • Lead in undertaking specialist audits of suppliers and within the organisation. Provide expert advice on the quality and development of medicines and specialist training for staff in the field of pharmaceutical manufacturing, quality and good manufacturing practice


Job Requirements

  • Extensive experience as a Qualified Person - prior experience working with Sterile products would be advantageous but not a pre-requisite
  • Experience of working within a commercial pharmaceutical organisation
  • Evidence of experience of the following specialist areas: QA, QMS, Supply Chain, Deviation management, Audit and Risk Assessment
  • Thorough understanding of legislation and official guidelines relating to Good Manufacturing Practice, and Quality Assurance in the UK, US and other regulatory agencies
  • Evidence of planning and development successes
  • Evidence of involvement in service development
  • Experience of FDA and MHRA inspection process
  • Involvement in Internal, External and Regulatory GMP audits


Qualifications

  • QP under EEC Directive 2001/83/EC
  • Pharmacy, chemistry or microbiology degree or equivalent
  • Further qualification (Post Graduate Diploma/MSC) within Pharmaceutical Technology or QA


We are looking for the successful candidate to possess strong influencing and leadership skills, with a fun down to earth personality who is comfortable engaging at all levels.

Qualified Person

TSP
Exeter, UK
Full Time

Published on 11/22/2021

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