This Band 7 senior role sits in the Aseptic Production Unit at Liverpool University Hospitals NHS Foundation Trust and is open to pharmacists or pharmaceutical scientists. The post holder oversees the quality of unlicensed medicines made and prepared in the unit, releases them on time and certifies that they meet the rules for pharmaceutical manufacturers. It also supervises less experienced staff, validates production processes and covers for the lead pharmacist, in a unit licensed in 2023. Registration with the GPhC, HCPC or RPS is required.
What the job involves
- Oversee the operational quality of production processes in a cost-effective and efficient way
- Assure the quality of all unlicensed medicines manufactured and prepared at the APU
- Ensure timely release of prepared and manufactured unlicensed medicines
- Certify unlicensed medicines as compliant with the Rules and Guidance for Pharmaceutical Manufacturers
- Validate production processes for compliance with aseptic preparation standards
- Contribute to product life cycle processes, including product development and product quality review
- Work closely with Aseptic Service Leads to steer quality programmes at the production unit
- Supervise less experienced pharmacists, scientists, technicians and students, providing training where necessary
- Troubleshoot and carry out risk assessments to guide the team in meeting medicines legislation
- Represent the APU at local and regional meetings when required
- Deputise for the Lead Pharmacists (Technical Services) as required
Qualifications
- M Pharm or equivalent, or an honours degree in pharmaceutical sciences, chemistry or similar combined with further training such as the MSc Scientist Training Programme in Clinical Pharmaceutical Sciences
Registration & licences
- Registered GPhC member and/or HCPC or RPS registration
Experience
- Experience of product development
- Evidence of working within GMP/GDP guidelines
- Evidence of significant, relevant and ongoing CPD
Skills & knowledge
- Knowledge of Good Manufacturing Practice and pharmaceutical manufacture regulations
- Knowledge of clean room design and functioning
- Highly developed professional knowledge underpinned by theory and experience
- Knowledge of COSHH Regulations and the Health & Safety at Work Act
- Leadership and motivational skills
- Problem solving and analytical skills
Other
- Planning and organisational skills, including prioritising demands and planning workload for self and others
- Highly developed interpersonal and communication skills with a range of people
- Capable team worker who builds and sustains good relationships
- Able to deal with constant interruptions, multiple pressures and at times aggression
- Methodical with attention to detail
Nice to have
- Technical qualification such as pharmacy, pharmaceutical technology, quality control, engineering or manufacturing
- Postgraduate certificate or diploma in a relevant pharmaceutical field
- Specialist knowledge of pharmaceutical manufacturing processes, including equipment and facility design, construction, validation and testing
- Knowledge of aseptic preparation, terminal sterilisation and QA/QC services
- Understanding of medicines management procedures
- Knowledge of product licensing and medical devices registration
- Experience of pharmaceutical manufacture in a hospital or industrial setting, or of managing an aseptic dispensing service
- Change management and project management skills
What's offered
- Support for further clinical and technical development