QA MFG Analyst

2 days ago

Dublin, Dublin City, Ireland Grifols, S.A Full time
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.

POSITION SUMMARY:

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 of the establishment of the Environmental Monitoring programme for aseptic manufacture and water systems for the manufacturing operations at GWWO. The successful candidate in this role will be required to work a 3-cycle shift in order to support manufacturing activities.

Quality Assurance Activities:

1. Reviewing and supporting sampling plans for water systems.
2. Routine sampling of Purified Water and Water for Injection.
3. Assisting and participating in qualification of clean rooms and sterilisation processes, aseptic gowning and other qualification processes where required.
4. Leading and participating in Environmental excursion investigations, deviations, CAPA and change controls and providing Quality support to the manufacturing area.
5. Supporting the spot check/walk-through process of the lines.
6. Supporting the annual product quality reviews if required.
7. Training of new Quality personnel where appropriate.
8. GMP implementation and site-wide Quality Awareness.
9. Liaising with other Department representatives to promote improvements in GMP and Quality standards.
10. Leading and implementing innovation, best practices and solutions for drug product manufacturing in collaboration with Quality teams from the Grifols sister sites.
11. Supporting sampling plans for Media Fill and Process Validation batches.
12. Liaising with Validation, Quality Control, Quality Manufacturing Assurance, Maintenance and the Operations team on execution of monitoring protocols. Providing quality performance information as required. Ensuring regular Quality interaction with other Departments.
13. Supporting any other additional activities as assigned by the QA manufacturing Monitoring Supervisor or the QA Manufacturing Manager.
14. Flexibility and willingness to carry out shift work.

PERSON SPECIFICATION

1. Knowledge & Skills
2. Self-motivated
3. Good organizational skills
4. Flexibility
5. Cleanroom performing Environmental Monitoring within the aseptic pharmaceutical/medical devices industry.
6. Deep knowledge and understanding of the aseptic regulatory requirements.
7. Grade C/D environmental monitoring experience.
8. Possibility of Grade A/B environmental monitoring experience.

Qualifications

1. 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:

1. Highly competitive salary.
2. Group pension scheme - Contribution rates up to 7%.
3. Private Medical Insurance for the employee.
4. Ongoing opportunities for career development in a rapidly expanding work environment.
5. Succession planning and internal promotions.
6. Wellness activities - Social activities e.g. 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.

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