Senior Qualified Person

Job Title: Senior Qualified Person

Location: London Bridge, SE1

Term: Permanent, Full-time

Salary: Competitive + Benefits (Private Medical, Private Dental, Pension, 25 days Annual leave plus bank holidays & Many more)

Richmond Pharmacology is a leading Contract Research Organisation (CRO) specialising in early-phase clinical trials for pharmaceutical and biotechnology sponsors. With a commitment to excellence and innovation, we strive to advance medical research and contribute to the development of life-changing therapies.

The Role:

The main purpose of the Senior Qualified Person is to complete duties as laid out in Directives 2003/94/EC, 2001/20/EC (as applicable), and 2001/83/EC and UK SI 2004/1031. This role is a legal requirement since Richmond Pharmacology operates according to Good Manufacturing Practices (GMP).

The Qualified Person carries out functions related to GMP Quality compliance objectives and ensure compliance to RPL Pharmaceutical Quality System.

Main duties and responsibilities:

• Complete QP duties as laid out in Directives 2003/94/EC, 2001/20/EC (as applicable), 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 IMP importation activities (eg QP oversight for the import of IMPs from Listed countries, importation of intermediates)


• 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


• Act as a subject matter expert within GMP Quality and Pharmacy areas


• Work effectively with RPL Customers to provide end to end QP support during the set-up and conduct of sponsor clinical trials at RPL


• Ensure Processes within your area of responsibility fully meet regulatory, business and customer expectations and targets.


• Review and approve non-conformances


• Manage GMP Change controls


• Manage GMP approved external suppliers

Additional responsibilities:

• Actively participate in the Site Quality council; present compliance the GMP Quality Objectives and the key issues impacting GMP Quality


• Maintain continuous professional development

Qualifications and Experience:

• Eligibility to act as Qualified Person in the UK


• BSc / MSc in Pharmacy or relevant scientific discipline


• Experience in IMP and Clinical trial, preferably in Phase 1 environment

Application:

If you are interested in the role, please register your details, including a copy of your CV.