Qualified Person (Hybrid)

Main Duties

• To carry out the duties and responsibilities of a Qualified Person as detailed in EU Directive 2001/83/EC and 2003/94/EC.
• To ensure that the GMP and GDP principles and duties, as outlined in the MHRA’s Rules and Guidance for Pharmaceutical Manufacturers and Distributors, are accurately interpreted and applied.

Participate in and manage the following quality systems;

• Review of batch documentation and subsequent batch disposition, including release certification
• Sampling, inspection, batch processing, and approval of bought-in products
• Liaison with contract laboratories and review of data generated following analysis
• Investigations into customer complaints
• Management of market recalls of pharmaceutical products
• Internal and external inspection programmes and representation of the department during regulatory inspections
• Review and process expired inventory, returns, and rejections
• Maintain contact with third-party warehouses, suppliers, and line management.
• To provide advice on product quality operations, ensuring conformity with registration particulars, GMP/GDP, and ensuring supply issues are rectified in a timely manner while maintaining stock levels.
• Represent the department in the processes of new product launch and product transfer, as well as providing feedback on relevant validation work.

Qualifications/Experience

• Eligible to act as a Qualified Person for the certification of marketed products in accordance with UK legislation
• BSc and or MSc in relevant scientific field
• Excellent verbal and written communication skills with the ability to work independently and within dynamic / collaborative cross-functional team environments
• Knowledge of manufacturing and packaging documentation, change control, qualification and validation process