Role: QP / Qualified Person - Pharma
Salary: Highly competitive
Russell Taylor Group has a fantastic opportunity for either a newly qualified QP looking for a new role or a more Senior QP. You must have a pharmaceutical background to be eligible to apply and have your QP licence number.
Working in accordance with the duties of a Qualified Person as defined in Article 51 of 2001/83/EC, key responsibilities include:
- Timely certification of the products, ensuring that the product is fit for its intended use, complies with the requirements of the relevant Manufacturing License, the Marketing Authorization (MA) and does not place patients at risk due to inadequate safety, quality and efficacy
- Ensure that all activities within the area are undertaken to established standards of cGMP
- To act as point of Contact with DMRC and MHRA Inspector
- To ensure effective risk management system is in place
- Lead the site in GMDP compliance
- To review and approved change controls, deviations, complaint and, Audit actions
- To conduct vendor approval and management
- To manage quality systems, processes and procedures to assure product quality and safety
- Influence site compliance to Quality policy, Quality Management System procedures and guidelines
- Lead internal/external quality audits.
- To host regulatory authority and customer audits
- Work with all Operations & Quality management to agree overall quality improvements and act as the driver for these improvements
- Provide Quality Assurance support on projects when required
- Eligible to be named as a Qualified Person.
- Experience over at least 2 years, in one or more undertaking which are authorised to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products.
- Pharma background