Qualified Person

Richmond Pharmacology; London; On-site; GBP 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a Qualified Person to join their dynamic team in London. This pivotal role involves ensuring compliance with Good Manufacturing Practices (GMP) and overseeing the quality assurance of clinical trial materials. You will be responsible for certifying investigational medicinal products (IMPs) for release, managing quality compliance objectives, and acting as a subject matter expert in GMP and pharmacy areas. Join a forward-thinking organization committed to advancing medical research and be part of a team that contributes to life-changing therapies. If you have a passion for quality and compliance in the pharmaceutical sector, this is the opportunity for you.

Benefits

Private Medical

Private Dental

Pension

25 days Annual leave plus bank holidays

Qualifications

• Eligibility to act as Qualified Person in the UK is essential.
• Experience in IMP and Clinical trials, preferably in Phase 1 environment.

Responsibilities

• Certifying IMP batches for release in clinical trials.
• Ensuring compliance with GMP Quality objectives and RPL Quality System.
• Promoting quality culture and continuous improvement initiatives.

Skills

GMP Compliance

Quality Assurance

Regulatory Knowledge

Clinical Trials

Pharmaceutical Knowledge

Education

BSc in Pharmacy

MSc in Pharmacy

Relevant Scientific Discipline

Job description

Job Title: 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 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).

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

Main duties and responsibilities:

1. 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
2. Mainly responsible for certifying IMP batches for release in clinical trials at Richmond Pharmacology Ltd.
3. Responsible for IMP importation activities (e.g., QP oversight for the import of IMPs from listed countries, importation of intermediates)
4. Carry out functions related to GMP Quality compliance objectives
5. Ensure compliance to RPL Pharmaceutical Quality System
6. Promote quality culture, identify GMP quality improvements, and enable implementation of continuous improvement initiatives
7. Setup, review, and approve new SOPs and Work Instructions
8. Act as a subject matter expert within GMP Quality and Pharmacy areas
9. Work effectively with RPL customers to provide end-to-end QP support during the set-up and conduct of sponsor clinical trials at RPL
10. Ensure processes within your area of responsibility fully meet regulatory, business, and customer expectations and targets
11. Review and approve non-conformances
12. Manage GMP change controls
13. Manage GMP approved external suppliers

Additional responsibilities:

1. Actively participate in the Site Quality Council; present compliance to the GMP Quality Objectives and the key issues impacting GMP Quality
2. Maintain continuous professional development

Qualifications and Experience:

1. Eligibility to act as Qualified Person in the UK
2. BSc / MSc in Pharmacy or relevant scientific discipline
3. 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.