QA Projects Officer
Posted 1 day 4 hours ago by Alliance Medical
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.
This role is suited to a quality professional with strong validation or QA experience who enjoys working across projects and multiple sites. You will be confident working in a regulated environment, able to build strong relationships and comfortable balancing hands on delivery with broader quality objectives.
Key Responsibilities- 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
- A degree in a scientific discipline (or equivalent experience) within a pharmaceutical or regulated manufacturing setting
- A 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