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QA Manufacturing Analyst
2 months ago
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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
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 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
Primary responsibilities for role:
1. General:
Act as a delegate for the quality monitoring supervisor when required.
2.Communication:
- 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
3.Quality Assurance Activities:
- 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.
- Liaise with other Department representatives to 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.
- To support sampling plans for Media Fill and Process Validation batches.
- To support any other additional activities as assigned by the QA manufacturing Monitoring Supervisor or the QA Manufacturing Manager
Person Specification
- Essential Knowledge & Skills
- 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
- Desirable Knowledge & Skills
- Grade C/D environmental monitoring experience.
- Possibility of Grade A/B environmental monitoring experience
Education and Qualifications:
Minimum of B.Sc Degree or equivalent third level education and at least 2 years’ experience working in an aseptic pharmaceutical/ medical devices industry.
Our Benefits Include:
- Highly competitive salary
- Group pension scheme - Contribution rates are 5% employer and 5% employee
- 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
We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you
Location: EMEA : Ireland : Dublin:Grange Castle (Dublin)
Learn more about Grifols
