Qualified Person

Walker Cole International is searching for a Qualified Person to join a Cell and Gene Therapy Biotech in Scotland. As the QP you will be a key part of managing the company's quality functions and performing batch release for both commercial and clinical 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 GMP is maintained across the facility which includes the manufacturing, testing and release activities.
• Performing Qualified Person's batch release activities for the business' products.  
• Driving and developing a positive quality culture on site, focussing on continuous improvement projects for the site. 

The successful candidate will have:

• The Qualified Person (QP) qualification under the provision of Directive 2001/83/EC and Directive 2001/82/EC.
• Extensive knowledge of biological products, aseptic/sterile manufacturing and IMPs. 
• Strong knowledge of cGMP, MHRA, FDA 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 | Biopharmaceutical | ATMPs | Cell and Gene Therapy | Advanced Therapy Medicinal Products