Description
Our global pharmaceutical client requires a Computer Systems Specialist with excellent knowledge of data integrity.The Data Integrity Specialist will support the review of the onsite computer systems as part of a remediation programme.
Main responsibilities
• Review onsite transversal systems, for example temperature mapping, with regards to data integrity
• Identify and report on gaps identified with respect to GMP guidelines
• Create a CAPA strategy to close all identified gaps and execute to drive for full adherence to GMP regulations
• Work with responsible persons for the other onside data integrity programs to ensure consistency and efficiency
• Provide expertise on systems data integrity to staff members to facilitate knowledge transfers
• Support with other remediation activities when aligned with area of expertise
Requirements
• Previous experience with Computer System data integrity review
• Strong knowledge of GMP requirements for transversal systems
• Previous experience of a Quality remediation programme desirable
• English language skills are essential
• French language skills desirable
• Pharmaceutical or biopharmaceutical experience