Crowe
Data Integrity and Application Specialist
Job Description
GE HealthCare is a leading global medical technology and digital solutions innovator with over 100 years of healthcare industry experience and around 50,000 employees globally. We enable clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by our Edison intelligence platform. We operate at the center of an ecosystem working toward precision health – digitizing healthcare, helping drive productivity and improving outcomes for patients, providers, health systems and researchers around the world.
Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world
Job Description
Key responsibilities regarding 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.
Key responsibilities regarding 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.
Required qualifications and characteristics:
- Relevant experience with Data Integrity in a pharmaceutical or related environment;
- Some experience and affinity with application development and -management
- Strong communication skills, both in English and Dutch;
- Programming experience in VBA, C# and SQL;
- Knowledge of CSV.
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.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or, age, disability, protected veteran status or other characteristics protected by law. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
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Additional Information
Relocation Assistance Provided: No
