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Qualified Person (Steriles)

Added on:
28 May 2021
Contract type:
Base Salary:


Excellent Career Opportunity to Join a Highly Successful, International Organisation which Provides a Range of Products and Services to the Healthcare, Life Science and Associated Sectors


  • Execute Qualified Person (QP) Responsibilities, Duties, Batch Certification and Disposition as Defined in 2001/83/EC, 2001/82/EC, 2011/62/EU and Eudralex Volume 4, Annex 16
  • Ensure Products are Manufactured in Accordance with GMP, Site Procedures and Applicable Regulatory Requirements
  • Maintain a Thorough and Up-to-Date Understanding of International Regulatory Guidance
  • Maintain and Extend Technical and Professional Competence, Ensuring a Thorough Understanding of Any New Product or Process, Prior to Any QP Batch Certification and Disposition
  • Undertake Regular Audits, Self-Inspections and Spot Checks
  • Undertake and Support Investigations, Root Cause Analysis and Review and Approve Major/Critical Deviation, Complaints and Any Change Proposals with Process/Product Impact
  • Undertake and Support the QMR Process
  • Undertake and Support Implementation of Operation Excellence
  • Act as Change Agent by Gaining Support for, and Driving Sustainable Improvements
  • Ensure Continuous Improvement of the QMS
  • Drive and React to System Trending eg Deviations, Complaints and Environmental Management, Ensuring Ongoing Quality Performance and Improvements.
  • Establish and Maintain Effective Communication with Clients
  • Backup for Other QP’s On-Site and Deputise for the Site Quality Director

REQUIRED (Essential)

  • Minimum Degree in Chemistry, Pharmacy or Microbiology
  • Minimum 3 years’ Experience Acting and Executing ‘Qualified Person’ Responsibilities and Duties as Defined in 2001/83/EC and 2001/82/EC
  • Substantial Experience Working in a Pharmaceutical Quality Function within a Sterile Manufacturing Site
  • Up-to-Date Knowledge of the Principles and Guidelines for GMP as per the UK “Orange Guide”, EU “Eudralex Volume 4”, US “CFRs” and Other Relevant Regulations
  • Excellent Scientific and Technical Knowledge

REQUIRED (Preferable)

  • Experience with Cephalosporins/Penicillin


  • £90K Subject to Qualifications and Experience


  • Call Luke Blaney on +44 (0)1580 211221 to Learn More about this Career Opportunity or e-Mail with Your Application, Including Your Current CV