Address Overview:
The Role
The Company
Fresenius Kabi is a global healthcare company that specialises in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used worldwide to help care for critically and chronically ill patients.
The Fresenius Group employs c.400,000 high-calibre professionals across the world, with a workforce of circa.1,000 professionals across the UK & Ireland.
The Role
Reporting to the Quality and Regulatory Director, the successful candidate will be leading the QC department with respect to product release to ensure provision of compliant product batches to the customer. This is an exciting opportunity to work within an Aseptic 'specials' environment as we continue to grow our compounding capacity. This role is critical in supporting the site and ensures the ongoing supply of Quality products and license to operate.
Responsibilities: - Manage the Quality Control Release teams to ensure resource is available to support the compounding unit demand / output
- Ensure batch disposition of medicinal products manufactured and supplied from the compounding centre is performed in a timely manner, ensuring that all batches have been produced and checked in accordance with the requirements of the manufacturer’s ‘specials’ licence and has been compounded, stored, and supplied in accordance with GMP
- Liaise with the production compliance team to support investigations where required, coming from deviations, complaints, or other issues
- Develop KPI’s and monitor and measure the team’s performance in relation to these KPI’s
- Drive improvements with regards to compliance and efficiencies within the QC release teams
- Ensure that systems are in place to support a compliant incoming goods process
- Ensure compliance with all recognised and relevant standards, internally and externally, to ensure patient safety and to comply with legislation as defined by government and statutory bodies
- Support regulatory inspections, internal audits, continuous improvement activities and projects
- Minimum Degree in Microbiology or Related Science
- Previous management experience working within pharmaceutical, microbiology or healthcare industries
- Strong communication and organisational skills
