QA Radiopharmacy Lead — GMP & Regulatory Compliance

Liverpool University Hospitals NHS Foundation Trust; Liverpool; On-site; AUD 133,000 - 209,000; Full time

Job summary

Liverpool University Hospitals NHS Foundation Trust seeks an experienced Quality Assurance leader to head the Radiopharmacy QA function within its Radiopharmacy Manufacturing Unit. You will ensure GMP compliance, MHRA licensing adherence and safe release of radiopharmaceuticals across Liverpool, Cheshire and the North West.

Working with the Chief and Deputy Chief Radiopharmacists, you will act as named Quality Controller on the MHRA Specials Licence, lead regulatory inspections, manage CAPA,

Qualifications

• Must lead the Radiopharmacy Quality Assurance function in GMP-regulated environment.
• Must ensure adherence to MHRA licensing and other relevant quality standards.
• Must act as named Quality Controller on MHRA Specials Licence and lead during inspections.
• Experience with deviation management, CAPA, change control and validation.
• Strong governance, risk management and quality improvement mindset.

Responsibilities

• Lead the Radiopharmacy Quality Assurance team and provide professional leadership for quality-related activities.
• Maintain and continuously improve the Pharmaceutical Quality System in accordance with GMP and MHRA requirements.
• Act as a named Quality Controller on the MHRA Manufacturer's "Specials" Licence.
• Lead quality activities during regulatory inspections and audits.
• Oversee deviation management, CAPA, change control, validation and quality risk management processes.
• Support the release of radiopharmaceutical products for clinical use.
• Lead GMP training and competency development within the department.
• Support the introduction of new services, technologies and radiopharmaceutical products.
• Contribute to strategic planning and service development within the Radiopharmacy Unit.
• Work collaboratively with internal and external stakeholders to ensure the continued delivery of safe, effective and compliant radiopharmacy services.

Skills

GMP Compliance

MHRA Licensing

QA Leadership

CAPA & Deviations

Change Control

Validation

Regulatory Inspections

Training & Development

Stakeholder Collaboration

Radiopharmacy QA

Job description

Liverpool University Hospitals NHS Foundation Trust seeks an experienced Quality Assurance leader to head the Radiopharmacy QA function within its Radiopharmacy Manufacturing Unit. You will ensure GMP compliance, MHRA licensing adherence and safe release of radiopharmaceuticals across Liverpool, Cheshire and the North West.

Working with the Chief and Deputy Chief Radiopharmacists, you will act as named Quality Controller on the MHRA Specials Licence, lead regulatory inspections, manage CAPA,