Senior Qualified Person

Richmond Pharmacology; London; On-site; GBP 40,000 - 70,000; Full time

Job summary

A leading Contract Research Organisation in London is seeking a Qualified Person for a permanent, full-time position. This role involves ensuring compliance with Good Manufacturing Practices and overseeing critical quality functions for clinical trials. Candidates must hold a relevant scientific degree and possess experience in the field. Benefits include competitive salary, private medical and dental coverage, and generous annual leave.

Benefits

Private Medical

Private Dental

Pension

25 days Annual leave plus bank holidays

Qualifications

• Eligibility to act as Qualified Person in the UK.
• Experience in IMP and Clinical trial, preferably in Phase 1 environment.
• Actively participate in the Site Quality council.

Responsibilities

• Certify IMP batches for release in clinical trials.
• Ensure compliance with GMP Quality compliance objectives.
• Manage GMP Change controls and approved external suppliers.

Skills

GMP Quality Compliance

Quality Improvement

Subject Matter Expertise in GMP

Education

BSc / MSc in Pharmacy or 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 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.

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