GE Qualified Person / Quality Assurance Specialist in Eindhoven, Netherlands

Job Number

2782652

Business

GE Healthcare

Business Segment

Healthcare Quality

About Us

GE is the world’s Digital Industrial Company, transforming industry with software-defined machines and solutions

that are connected, responsive and predictive. Through our people, leadership development, services, technology

and scale, GE delivers better outcomes for global customers by speaking the language of industry.GE Healthcareprovides transformational medical

technologies and services to meet the demand for increased access, enhanced quality and more affordable

healthcare around the world. GE works on things that matter - great people and technologies taking on tough

challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery,

biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps

medical professionals deliver great healthcare to their patients.

GE is committed to taking on the world’s toughest challenges. In order to fulfill that promise we rely on a culture of

leadership, diversity and inclusiveness. We aim to employ the world’s brightest minds to help us create a limitless

source of ideas and opportunities. We believe in hiring talented people of varied backgrounds, experiences and

styles…people like you!

Posted Position Title

Qualified Person / Quality Assurance Specialist

Career Level

Experienced

Function

Quality

Function Segment

Quality Assurance

Location(s) Where Opening Is Available Netherlands

City

Eindhoven

Postal Code

5612 AP

Relocation Assistance

No

Role Summary/Purpose

The Qualified Person (QP) is responsible under EC law to the regulatory authorities for ensuring that the pharmaceutical products supplied have been manufactured, controlled and distributed in accordance with procedures embodied in the various licenses and in accordance with pharmaceutical Good Manufacturing and Distribution Practice and that in all respects they are safe and suitable for the use for which they have been supplied.

Essential Responsibilities

  • Responsible for the review of batch manufacturing records and the process of manufacture supporting the decision to release product in compliance with all license and GMP requirements.

  • As Qualified Person, required to review requests to vary the process of manufacture as a result of local events and specify any additional work required in order for product to be safe and efficacious.

  • Assess existing and proposed facilities and working practices and ensure GMP compliance.

  • Represent QA on a range of development projects and advise on the adequacy of validation of facilities, equipment and new products/processes, including designing strategies to ensure adequate data is gathered.

  • Accompany and coordinate regulatory inspections from external bodies.

  • Support the QA audit function to ensure GMP compliance both within the company and at key suppliers.

  • Contribute to the development of policy within the QA organization.

  • Manage and participate in projects as the QA representative to meet business objectives. 

  • Coordinate Product Corrective Action activities and liaise with the regulatory agencies as appropriate in these circumstances.