Computer System Validation Expert (GxP)
myTomorrows is an independent, globally operating organization based in the Netherlands. We provide patients with unmet medical needs and their doctors with information about treatment options worldwide and facilitate access to medicines in development.
We are changing the world of healthcare
By digitizing, organizing and making accessible key healthcare information, we can make a real difference to real people with real illnesses, all over the world. Our goal is to ensure that patients and doctors don’t miss out on treatment options due to lack of information, understanding and administrative hurdles. Through our efforts to support patients and their doctors, we believe we can help patients from all around the globe.
What will you do – Computer System Validation Expert (GxP)
To strengthen our team, we are looking for a Computer System Validation Expert (GxP) to add value to our business. In collaboration with our Quality and technology teams, you will assist in the setup and maintenance of the Quality Management System for Computer System Validation (Policies, VMP, Standard Operating Procedures, Instructions and Templates)
So in short, you will be responsible for:
- The preparation of the documentation required for computer system validation (change control, risk assessment, URS, traceability matrix, test plan, validation plan, validation report etc.);
- The execution and documentation of tests as part of computer system validation;
- The execution and documentation of infrastructure validation;
- The qualification of computer system / software suppliers;
- Periodic evaluation of the validated computer systems and subsequent reporting.
Your role will be to:
- Act as Subject Matter Expert regarding CSV during regulatory inspections and client audits as well as selection and qualification of contract parties,
- Work closely with the product owner and project manager within the tech team to translate findings and requirements into use-cases and technical sprints,
- Work with the tech team leads to advocate quality thinking and increase the awareness of working within a validated environment.
Compensation & Benefits
Our team is driven, caring, and determined. While we come from different backgrounds and disciplines, each member of our team contributes expertise that, combined with our technology platform, provides patients and their doctors the keys to drive the necessary change.
Other than working with a great team of young, smart and energetic people, we also offer:
• A competitive benefits package;
• An open and friendly work environment where we empower people and provide them with opportunities to develop themselves and their career;
• Friday afternoon drinks and various nice events.
Please send your application to firstname.lastname@example.org. For questions please feel free to contact Sanne Scheffers via email@example.com.