POSITION SUMMARY
QA Environmental Monitoring 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.
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.
KEY RESPONSIBILITIES
Act as a delegate for the quality environmental supervisor when required.
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
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
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
Minimum of B.Sc Degree or equivalent third level education and at least 2 years' experience working in an aseptic pharmaceutical/ medical devices industry.
Grade C/D environmental monitoring experience.
Possibility of Grade A/B environmental monitoring experience.
Our Benefits Include
Highly competitive salary
Group pension scheme – Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
Private Medical Insurance for the employee
Ongoing opportunities for career development in a rapidly expanding work environment
Succession planning and internal promotions
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
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