GE HealthCare Data Integrity Application Specialist 

Netherlands 

39978357

In this role you will be leading our site in the implementation of Data Integrity (DI) and maintain the software of our applications in close cooperation with our Quality Assurance Team and Application Specialist. This role is based in Eindhoven and requires fluent Dutch.

***Dutch speaking, no relocation, located in Eindhoven***

Essential Responsibilities Data Integrity

• Responsible for the execution of the DI strategy for the site via new initiatives or improve existing applications or processes.
• Ensure site employees are trained and aware of DI requirements.
• Work with multidisciplinary teams to ensure GxP data is being generated and managed, compliant with DI requirements, throughout its lifecycle.
• Act as the DI SME to meet DI requirements in projects and changes within the site and/or lead small projects or change controls with the specific goal to improve on DI compliancy.
• Work with document and template authors to ensure good documentation practices for electronic and paper based data.
• Support function/site based regulatory audits as the DI SME liaising with with Production, Engineering, IT, Validation and Quality Departments as required.
• Manage and support a program of internal audits of all DI processes, using a risk-based approach. Ensure all identified actions are completed in a timely manner.
• Work in collaboration with other site DI Leads and SMEs to deliver the DI program.
• Identify deficiencies and support process owners to bring processes in line with guidelines.
• Keep up to date with latest guidelines and regulations on DI.

Essential responsibilities Application Development and Management

• Creating functional designs and testing new functionalities of applications.
• Project-based implementation and validation of new applications and systems.
• Advise / participate in projects specific on software and Computer System Validation (CSV)
• Improve data collection methods.
• Manage current GxP status of existing systems.
• Point of contact for key users and software suppliers.
• Advising local management on necessary or desired adjustments within applications or systems.

Basic qualifications

• Bachelor degree in LifeSciences or related field
• Relevant experience in a QA role with a pharmaceutical or related company
• Relevant experience with Data Integrity in a pharmaceutical or related GMP production environment;
• Some experience and affinity with application development and -management
• Strong communication skills, fluent Dutch and English;
• Knowledge of CSV.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support