Senior GMP QA Specialist (12-month FTC Maternity Cover)

The Senior QA Specialist is responsible for the GMP oversight of clinical phase, gene-modified cell therapy product manufacturing and testing. The role includes execution and reporting of outsourced GMP PQS systems, design and improvement of Quell PQS systems, and oversight of outsourced GMP activities.

Requirements

• Previous experience pharmaceutical quality assurance supporting the development and GMP manufacture of ATMPs,
• Working knowledge of regulatory requirements (UK and EU GMP, ICH) for clinical stage sterile products, including ATMPs
• High attention to detail, strong organisational and communication skills

Benefits

• Holidays: 25 days per year
• Life Assurance: 4 x base salary
• Group Personal Pension: Auto-enrolled at 6% employer contribution, 3% employee contribution
• Private Medical Insurance for your whole family
• Health Cash Plan
• Annual Bonus