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The Company 
Our client is the leader in the field of biomedicines. Through the dynamic science of biotechnology, they continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders. 

Role Description 
As a Data Integrity SME you will share your expertise and ensure that the Data Integrity Project for manufacturing / production systems are meeting its goals. You'll also be executing remediation actions to ensure that computerized manufacturing systems meet the requirements of Data Integrity

Responsibilities 
- Performing Data Integrity assessment, analyzing DI gaps and support on DI remediation
- Support Business and System Owners in expectations to Data Integrity 
- Understanding both technical and procedural requirements of DI applied to manufacturing systems in a GxP /PLC / HMI/ SCADA / MES environment
- Writing, reviewing system administration SOPs, Work Instructions, URS for enterprise DI integrity 
- Supporting QA in managing quality, investigations, deviations and CAPAs related to DI 


Requirements 
- Relevant degree in computer science, engineering, or equivalent 
- Extensive knowledge of regulatory requirements for Data Integrity for Pharma manufacturing computerized systems 
- Min. of 4 years of GxP Pharma work experience 
- Regulatory requirements on how data is managed (from creation to deletion)
- Gap identification by using assessments (write a procedure, review process to be set up) 
- Work experience within Quality Assurance dpt. or in the field of computerized systems Quality / validation is strongly preferred
 

Other information
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