Job Information
Grifols Shared Services North America, Inc QA Manufacturing Specialist in Dublin, Ireland
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 role of the QA Manufacturing Specialist is to 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).
KEY RESPONSIBILITIES
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.
Support the Aseptic Process Simulation and Batch Manufacture activities including observation of critical interventions as required for batch review.
Qualify in gowning for entry to Grade A/B area.
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.
PERSON SPECIFICATION
Excellent communication skills
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
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
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Learn more about Grifols (http://www.grifols.com/es/web/international/home)
Req ID: 522799
Type: Regular Full-Time
Job Category:
Grifols Shared Services North America, Inc
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