Focusing on drug innovations to improve and extend the quality of people’s lives, my client aims to make crippling illnesses history. Located in Leiden, they are a part of the largest global pharmaceutical company that produce complex biologicals and COVID-19 vaccines among many life changing products.
As a Data Integrity Specialist your goal is to execute remediation plans to ensure the computerized manufacturing systems meet current Data Integrity requirements. As part of the site data integrity team, you will be remediating system gaps within a complex pharmaceutical environment.
- Analyze data integrity gaps and execute remediation
- Guide stakeholders in current data integrity expectation
- Share DI best practices
- Develop & improve system administration SOPs, URS, and work instructions for regulatory & enterprise DI requirements
- Understand requirements within a GxP PLC/HMI/SCADA/MES environment
- Identify most efficient action at any step of the data flow
- At least a Bachelor’s Degree in computer science, engineering or similar fields
- Extensive knowledge & up-to-date in regulatory requirements for Data Integrity in a pharmaceutical manufacturing computerized system
- Experienced in Computerized System Validation and/or Data Integrity
Does this role interest you? Questions? Simply apply to this vacancy and I will be in touch.