Qualified Person

7 days ago

London, United Kingdom Richmond Pharmacology Full time

Richmond Pharmacology is a leading medicines research organisation based in the heart of London, engaged in the testing of new medicines targeting both rare disease areas and those diseases that impact huge global populations.

We conduct clinical trials on a multitude of volunteer panels including healthy young, elderly, Japanese and patients from primary and secondary care; to develop new medicines, treatments and cures for the future, helping to improve the quality of life for others.

As a Qualified Person you will be responsible for assuring batches of medicinal products have been manufactured and assembled in compliance with the GMP legislation as well as assist in the maintenance of the company’s quality management systems and first class standard operating procedures.

You will work closely with the Principal Investigator, Research Physicians, Project Managers and other core members of the clinical project team to ensure safe and efficient conduct of clinical trials. This role will offer you an excellent opportunity to further your experience in clinical research regulatory matters.

**Key Responsibilities**
- Complete QP duties as laid out in Directives 2003/94/EC, 2001/20/EC, and 2001/83/EC and UK SI 2004/1031
- Mainly responsible for Certifying IMP batches for Release in clinical Trials at Richmond Pharmacology Ltd.
- Responsible for QP oversight for the import of IMPs from Listed countries
- Carry Out functions related to GMP Quality compliance objectives
- Ensure compliance to RPL Pharmaceutical Quality System
- Promote Quality Culture, Identify GMP Quality improvements and enable implementation of continuous improvement initiatives
- Setup, review and approve new SOPs and Work Instructions
- Work effectively with RPL Customers to set new supply chains and provide end to end QP support during the conduct of sponsor clinical trials at RPL
- Ensure Processes within your area of responsibility fully meet regulatory, business and customer expectations and targets.
- To review and approve deviations and non-conformances
- Actively participate in the Site Quality council; present compliance t GMP Quality Objectives and the key issues impacting GMP Quality
- Maintain continuous professional development

**Experience**
- Qualified person in accordance with Directive 2001/20/EC., and / or Qualified person in accordance with Directive 2001/83/EC.
- BSc / MSc in Pharmacy or relevant scientific discipline
- Experience in IMP and Clinical trial, preferably in Phase 1 environment
- Very good numerical skills required

If you believe that you have the skills and experience necessary for this role and would like to apply, please submit a current copy of your CV via our Bamboo HR web portal. You will be asked to supply basic contact details along with your CV.

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