QA Manufacturing Analyst

QA Manufacturing Analyst

Grifols

Dublin, Ireland

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:

General:

• Act as a delegate for the quality monitoring 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

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.

Apply Now

More Job Searches

Ireland      Manufacturing and Logistics      Medical Devices      Quality Assurance      Grifols