The CompanyFresenius 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.As a Quality Systems Specialist, you will be reporting to the QMS Manager and will provide dedicated quality oversite and support across the site. The role is full-time, Monday - Friday and is based in Runcorn.ResponsibilitiesEnsure robust and effective change management and deviation management systems are in place to meet regulatory requirementsProvide support to the site in completion of quality investigations, robust root cause analysis and relevant CAPA through training and mentoringEnsure all QMS activities requiring QA review/input are completed to a high standard within required timeframesDevelop and report on quality KPI’s to identify trends and improvements neededIdentify, design and deliver GMP training to staff in order to support improved application of GMP/GDP standardsImplementation of appropriate risk management policies, procedures, systems, and processes, ensuring evaluation processes are effectively applied across the siteIdentifying areas of continuous improvement in terms of Quality Culture, Compliance and Site quality systemsExperience/qualificationsExperienced QA Professional with extensive GMP/QMS ExperienceScience/pharmacy-based degree (or equivalent)Strong communication and influencing skillsExperience with Change Control, Deviation and Investigation management, Root cause analysis and CAPAExperience in the use of TrackwiseExperience in Quality Risk ManagementRobust understanding of sterile productionBenefitsPrivate healthcareContributory Pension Scheme (rises with service)Role specific tailored training and development planLife Insurance (4 x salary, death in service)25 days holiday (rises to 27 after 5 years service) and ability to buy/sell holidaysMaternity, Paternity and Adoption LeaveProfessional fees paidBike to work schemeLong Service AwardsEmployee Assistance ProgrammeFree onsite parking and subsidised canteenBlue Light CardCharity Fundraising & Volunteer DaysCompany funded family days outWe are proud to foster a workplace free from discrimination. Diversity of experience, perspectives, and background create a better work environment and better products. Whatever your identity, we will give your application fair consideration.