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.

The QA Manufacturing Specialist is required for a new purification and aseptic filling plant for the blood protein albumin at Grifols Worldwide Operations (GWWO). Reporting directly to the QA Manufacturing Supervisor of Grifols Worldwide Operations (GWWO), the successful candidate will complete and support activities within the Quality Department relating to GMP Compliance and to provide Quality support for the aseptic manufacturing operations in Grifols Worldwide Operations Ltd (GWWO). The successful candidate must also demonstrate extensive knowledge and understanding of Annex 1 and aseptic regulatory requirements.

What will you be doing?

General:

Act as a representative for the Quality team in the absence of the quality supervisor/manager

Communication:

Daily briefing on Quality batch review/approval
Provide quality performance information as required
Ensure regular Quality interaction with other Departments

Quality Assurance Activities:

Support method transfer plans, qualification of sampling plans for water systems, raw materials, environmental monitoring, in- process and FP testing
Assist and participate in qualification of cleaning processes, clean rooms and sterilisation processes aseptic gowning and other qualification processes where required. Review and approval of qualification pack.
Qualify in gowning for entry to Grade A/B area.
Support the Aseptic Process Simulation and Batch Manufacture activities including observation of critical interventions as required for batch review.
Review of Batch Records.
Lead and/participate in technical deviations, investigations, CAPA and change controls and provide Quality support to the manufacturing area.
Maintain a high level of technical writing expertise and stay current with regulatory trends.
Involve in customer complaint investigation if required.
Reviewing and approving SOP’s, validation protocols and reports and other GMP documentation
Support internal GMP audits and support the continuous improvement initiatives and regulatory requirements for quality monitoring.
Perform the spot check/walk-through process of the area.
Support the annual product quality reviews if required.
Act as back room support during any external audit/inspections.
Represent Quality in the project management for any Process/product/system improvement projects.
Participate in quality risk management, to provide quality expertise and technical support to the Albumin manufacturing area.

Who You Will Be?

Excellent communication skills
Deep knowledge and understanding of the aseptic regulatory requirements
Minimum of B.Sc Degree and at least 3 years’ experience in a quality or production function within the aseptic pharmaceutical/medical devices industry
Strong technical writing skills.
Competence in Microsoft packages specifically word, excel and PowerPoint
Good organizational skills
Flexibility
Results orientated
Ability to make decisions
Ability to handle multiple projects and deadlines.

What we offer?

Highly competitive salary
Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
Private Medical Insurance for the employee (Irish Life)
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

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Location: EMEA : Ireland : Dublin:Grange Castle (Dublin)

Learn more about Grifols

QA Manufacturing Specialist

Benefits

Job Description