Quality Assurance Manufacturing Analyst is required for a new purification plant for the blood protein albumin at Grifols Worldwide Operations (GWWO).
This role offers a chance to work in a state-of-the-art facility, in an innovative Biotechnology company with excellent career development opportunities and a clear and committed patient focus.
Reporting directly to the Quality Assurance Monitoring Supervisor of GWWO the role is for an experienced analyst who will perform aseptic sampling and environmental monitoring as part in the establishment of the Environmental Monitoring programme for aseptic manufacture and water systems for the manufacturing operations at GWWO.
Responsibilities Communication:Liaise with Validation, Quality Control, Quality Manufacturing Assurance, and the Operations team on execution of monitoring protocols.Provide quality performance information as required
Quality Assurance Activities:Reviewing and support sampling plans for water systems.Routine sampling of Purified Water and Water for InjectionAssist and participate in qualification of clean rooms and sterilisation processes, aseptic gowning and other qualification processes where required.Lead and/participate in Environmental excursion investigations, deviations, CAPA and change controls and provide Quality support to the manufacturing areaSupport the spot check/walk-through process of the linesSupport the annual product quality reviews if requiredTraining of new Quality personnel where appropriateGMP implementation and site-wide Quality AwarenessLiaise with other Department representatives to promote improvements in GMP and Quality standardsLeading and implementing innovation, best practices and solutions for drug product manufacturing in collaboration with Quality teams from the Grifols sister sitesTo support sampling plans for Media Fill and Process Validation batchesTo support any other additional activities as assigned by the QA manufacturing Monitoring Supervisor or the QA Manufacturing Manager
- Excellent communication skills
- Good organizational skills
- Minimum of B.Sc Degree or equivalent third level education and at least 2 years' experience working in an aseptic
- Cleanroom performing Environmental Monitoring within the aseptic pharmaceutical/medical devices industry.
- A deep knowledge and understanding of the aseptic regulatory requirements