Qualified Person

Walker Cole International is searching for a Qualified Person to join a Pharmaceutical company with manufacturing facilities in the South East of London. As a QP you will be a key part of managing the company's quality functions and performing batch release activities. 

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.
• Carrying out Qualified Person's batch release responsibilities of the company's products. 
• Managing and conducting both internal and external audits. 

The successful candidate will have:

• Qualified Person (QP) qualification under the provision of the UK Statutory Instruments 2012/1916 and 2004/1031.
• Experience within sterile or aseptic clean room environments.
• Strong knowledge of cGMP, MHRA, FDA and EU guidelines. 
• Strong leadership, communication and organisational skills with a pragmatic quality mindset.

Quality Assurance | QA | Qualified Person | Pharmaceutical | CAPA | Corrective and Preventative Action | Quality | eQMS | PQS | Pharmaceutical Quality System | Batch Release | QP | GMP | Good Manufacturing Practice | QMS | Quality Management System | Operational | IMP | Investigational Medicinal Product | Commercial | GCP | Sterile | Biopharmaceutical