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We are seeking a QA Projects Officer to provide quality and validation support across Alliance Medical Radiopharmacy’s UK operations. Reporting to the Validation & Project QA Manager, this role sits within the wider Quality function and works closely with site QA, QC, Operations and Project teams across the UK network. The QA Projects Officer plays a key role in supporting both routine commercial operations and development activities, helping to ensure consistent quality standards, robust GMP systems and ongoing inspection readiness in a highly regulated radiopharmacy and sterile manufacturing environment.
Job Responsibility:
Providing QA and validation support across all UK Radiopharmacy facilities
Supporting inspection readiness and participating in client audits and regulatory inspections
Acting as an advisor to site teams on validation, projects and quality continuous improvement activities
Supporting commercial and IMP project activities from a QA perspective
Ensuring consistent application of GMP, GDP and MHRA requirements across sites
Supporting regulatory interactions with the MHRA and other authorities, including audit responses and ongoing compliance actions
Managing and harmonising project documentation, including deviations, CAPAs, change control and risk management
Reviewing and approving quality and regulatory documentation, including SOPs, batch documentation and validation protocols
Providing QA input into product development, technology transfer and validation activities within sterile and radiopharmacy environments
Supporting project teams in driving continuous improvement and quality culture across the UK network
Delivering or supporting quality and validation training when required
Acting as a role model for quality, compliance and best practice
Requirements:
Degree in a scientific discipline (or equivalent experience) within a pharmaceutical or regulated manufacturing setting
Strong background in QA, validation, qualification or quality systems, ideally with 5+ years experience
Experience working within radiopharmacy, nuclear medicine, sterile manufacturing or aseptic processing environments
Demonstrable experience supporting commercial products and IMP development activities
Strong working knowledge of UK and EU GMP, MHRA requirements and GxP compliance
Experience supporting audits, inspections and regulatory authority interactions
Experience working across multi-site operations and engaging multiple stakeholders
Excellent written and verbal communication skills
Strong organisational skills with a high level of attention to detail
Ability to work proactively and independently while contributing effectively to team objectives
Confident, collaborative approach with the ability to lead by example in quality and compliance