CMDO is Seeking to Appoint a Qualified Person. The Organisation is Engaged in Developing and Manufacturing New Medicines and Novel Formulations, Including a Wide Range of Oral Solid and Liquid Dosage Forms, Sterilised and Aseptically Filled Products, as well as Manufacturing and QP Certification of a Range of Phase I/II Clinical Trials for the UK and EU Markets,

ROLE

• Perform the Legal Duties of a Qualified Person (QP) on the MIA(IMP) as Specified under EC Directive 2001/20/EC and Human Medicines Regulations 2012
  
  
• Ensure Compliance with the Requirements of Eudralex Volume 4, Part 1, Annexes 13 and 16
  
  
• Undertake QP Batch Certification and Release Functions within Departments Named on the Relevant Site Manufacturers Authorisation (IMP)
  
  
• Responsible for All QP Activities and Associated Resource Planning, Training, Development and Management
  
  
• Ensuring the Completeness and Effectiveness of the of Pharmaceutical Quality Management System and Pharmaceutical Quality Control Service as per the requirements for the Qualified Person, Described in Human Medicines Regulations 2012 and EudraLex Volume 4, Part 1, Annex 13 and Annex 16.
  
  REQUIRED
  
  
• Masters Degree in Pharmacy, Biochemistry, Chemistry, or Life Sciences
  
  
• Extensive Specialist Knowledge and Experience of Batch Certification/Release of Sterile Injectable Manufacture, Manufacture of Specials (Unlicensed) Medicinal Products, Investigational Medicinal Products for Clinical Trials and Radiopharmaceuticals
  
  
• Eligibility to Function as an EU QP for Investigational Medicinal Products under Statutory Instrument 2004:1031
  
  
• Eligibility to Function as an EU QP Under the Permanent Provisions for Medicinal Products Under Statutory Instrument 2012:1916
  
  
• Extensive Experience in GMP Validation of Pharmaceutical Facilities, Utilities, Equipment, Processes and Analytical Methods
  
  
• Managerial Experience in a Pharmaceutical Organisation and a Track Record of Compliance at Regulatory Inspections
  
  
• Experience of Research and Supply of IMP Medicines for Clinical Trials
  
  
• Expert Knowledge of GCP, GMDP, Quality Systems and Pharmaceutical Analysis
  
  
• Expert Knowledge of Pharmaceutical Microbiology and Quality Control
  
  
• Expert Practical Knowledge of GCP, GMDP, QA and All Current Relevant Regulations
  
  
• Expert Technical Knowledge of Pharmaceutical Sterile and Non -Sterile Manufacturing
  
  
• Demonstrable Ability to Risk Assess, Perform Root Cause Analysis and Resolve Deviations and Out of Specification Results and Develop Suitable CAPAs
  
  
• Demonstratable Ability to Ensure Quality through Set-Up, Manufacturing and Release of IMPs under a MAIMP to Comply Fully with the Requirements of GMP and GCP
  
  REMUNERATION
  
  £90K, Subject to Qualifications and Experience