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Qualified Person

Added on:
31 Oct 2019
Contract type:
Home Counties
Base Salary:


Based in the Home Counties and Reporting to the Pharmaceutical Director, this is an Opportunity for a QP to Establish Themselves as a Key Member of the Leadership Team of this Major Supplier of Pharmaceutical Products

Primarily Responsibility for the Certification of Products with Other Associated Responsibilities



  • Able to Display and Communicate an In-Depth Knowledge of cGMP Regulatory Standards, Licensing the Unlicensed Products and Sterile Production
  • Review and Approval of Standard Operating Procedures
  • Review and Approval of Study Protocols and Auditing (Internal and External)
  • Auditing for GMP, GCP, GDP and GLP Purposes
  • Experience of Quality Management Systems, Covering All Aspects of Licensed Manufacturing Sites
  • Active Participation in Troubleshooting of GMP, GCP and GLP Issues
  • Input into the Regulatory Strategy for the Development of Pharmaceutical Products in the UK
  • Licensing the Unlicensed Medicines for the UK Market
  • Liaising with the Regulatory Authority/MHRA Contact for All Pharma Products Sold in UK
  • Working Cross Functionally with Pharmacovigilance, Regulatory Affairs and Clinical Research
  • Involvement in All Aspects of Sterile Production, Including Design, Installation and Operational
  • Plan, Execute and Supervise Standard Training Programmes for All New Employees and Maintain Continuous Training for All Staff
  • Develop Training Courses as a Separate Business Unit Within the Department
  • Maintain All Professional Knowledge Databases
  • Other Projects and Other Assignments



  • Eligible to be Named as a Qualified Person
  • Licensed Manufacture of a Range of Dosage Forms, (Solid Oral, Liquid Oral, Sterile, Semi-Solid and Topical)
  • Parallel Import Operations
  • Practical Auditing for GMP, GCP, GDP and GLP Purposes
  • Quality Management Systems



  • Basic Salary of £80K Per Annum



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