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