CSV Engineer

France  ‐ Onsite
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Keywords

Support

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
Start date
n.a
From
Quanta Consultancy Services
Published at
25.08.2016
Contact person:
Lee Mitchell
Project ID:
1192480
Contract type
Freelance
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