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About the role
- QA Manufacturing Analyst at Grifols for aseptic sampling and environmental monitoring in a new plant. Supporting manufacturing activities and ensuring quality standards in operations at GWWO.
Responsibilities
- The QA Manufacturing Analyst is required for a new purification and aseptic filling plant for the blood protein albumin at Grifols Worldwide Operations (GWWO).
- Reporting directly to the Quality Assurance Monitoring Supervisor of GWWO.
- 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.
- Work a 3-cycle shift in order to support manufacturing activities. 24/5 HOURS 7-7
- Reviewing and support sampling plans for water systems.
- Routine sampling of Purified Water and Water for Injection.
- Assist 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 area.
- Support the spot check/walk-through process of the lines.
- Support the annual product quality reviews if required.
- Training of new Quality personnel where appropriate.
- GMP implementation and site-wide Quality Awareness.
- Promote improvements in GMP and Quality standards.
- Leading and implementing innovation, best practices and solutions for drug product manufacturing in collaboration with Quality teams from the Grifols sister sites.
- Support sampling plans for Media Fill and Process Validation batches.
- Liaise with Validation, Quality Control, Quality Manufacturing Assurance, Maintenance and the Operations team on execution of monitoring protocols.
- Provide quality performance information as required.
- Ensure regular Quality interaction with other Departments.
- Support any other additional activities as assigned by the QA manufacturing Monitoring Supervisor or the QA Manufacturing Manager
Requirements
- Minimum of B.Sc Degree or equivalent third level education
- at least 2 years’ experience working in an aseptic pharmaceutical/ medical devices industry
- Excellent communication skills
- Self-motivated
- Good organizational skills
- Flexibility
- Cleanroom performing Environmental Monitoring within the aseptic pharmaceutical/medical devices industry.
- Deep knowledge and understanding of the aseptic regulatory requirements
- Grade C/D environmental monitoring experience.
- Possibility of Grade A/B environmental monitoring experience.
Benefits
- Highly competitive salary
- Group pension scheme - Contribution rates up to 7%.
- Private Medical Insurance for the employee
- Ongoing opportunities for career development in a rapidly expanding work environment
- Succession planning and internal promotions
- Education allowance
- Wellness activities - Social activities eg. Padel, Summer Events
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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