QA Manufacturing Specialist in Home Office, Germany

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: