Job Description
Working at the Liverpool site as part of the Global SA team under general direction from the Snr Manager of Sterility Assurance, this candidate is to provide sterility assurance support for the Seqirus Liverpool and relevant CMO Sites. They will support (and deputise for) the Snr Manager and will focus their efforts to ensure that from an aseptic perspective, the day to day manufacturing operation runs in accordance with its validated status, all SOPs, the Quality manual and Good Manufacturing Practice.
They will also advocate/lead necessary change management processes, participate in complex manufacturing investigations including product impact assessment and maintain their own knowledge/expertise to be recognised as a site SME and act as such during regulatory inspections. They will participate in the design and delivery of training programmes. They will be competent to author product impact assessments and working closely with the site QA team assist in batch disposition decisions.
1. Under the guidance of the Sr Manager Sterility Assurance, to collaborate with the manufacturing leadership teams and to spend time in manufacturing areas and provide broad consultation/support for sterility assurance issues both in LVP as well as 3rd party manufacturing facilities that work on behalf of Liverpool. Management of complex deviation investiga...