IMP Qualified Person

Walker Cole International is searching for a Qualified Person to join a Clinical Trial Manufacturing facility in London. As a QP you will be a key part of managing the company's quality functions and performing batch release activities on Investigational Medicinal Products. 

You will be responsible for:

• Developing, and maintaining the QMS and Compliance strategy to ensure they meet current GMP regulations and regulatory standards. 
• Ensuring all manufacturing, testing and release activities are carried out in accordance with current GxP standards.
• Performing Qualified Person's batch release activities for clinical trial products. 
• Liaising with internal and external stakeholders in the business regarding compliance activities across the site. 

The successful candidate will have:

• Experience performing the duties of the Qualified Person(s) as described in Article 51 of Directive 2001/83/EC and the applicable UK Statutory Instrument
• Extensive experience working with early phase clinical trial products 
• Strong knowledge of cGMP, MHRA, and EU guidelines. 
• Proven leadership skills showcased by previous managerial or supervisory experience. 

Quality Assurance | QA | Qualified Person | Pharmaceutical | Quality | eQMS | Batch Release | QP | GMP | Good Manufacturing Practice | QMS | Quality Management System | IMP | Investigational Medicinal Product | Clinical Trials