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CSV Consultant

  1. Norway
  1. Contract
Competitive
26005
  1. Commisions, Qualification and Validation
Date Posted05 Jan 2021
How would you like the opportunity to work with a global life sciences organisation based in Norway?  If yes, then this is the assignment for you!

Our client specialises in providing lifesaving medicines and technologies and their site in Norway manufactures products that are used globally in over 50 different countries.

The client is currently looking to add the skills of a CSV Data Integrity Consultant to their team to support ongoing activities and planned activities. The successful candidate will provide support and perform activities related to data integrity (DI) and computer system validation (CSV).


Essential Duties and Responsibilities for this role include, but are not limited to, the following:
• Alarm management for production GxP system –
o Define GxP relevant alarms
o Define GxP critical alarms
o Define action upon GxP critical alarms
o Update SOP with action
• Computer system validation (QC and Production systems)
o Support validation of; Density, pH and conductivity meter
o Prepare Protocols; URS -> DQ -> IQOQPQ
o Perform validation and qualification testing
• Configuration of SCADA system (user management and security)
o Identify system that may be interfaced with SCADA system
o Interface HMI/PLC with SCADA
o Setup user management and permissions
o Configure security policy
• Provide CSV expertise and training to local resources
• Process mapping with respect to DI compliance

Desirable Experience:
The candidate need to have experience in several of these field:
• Extensive CSV work on Manufacturing Automated and Computerised System (e.g. SCADA, Siemens HMI)
• Previous experience with CSV work on laboratory equipment
• GAMP5 knowledge
• Previous Data Integrity experience
• A strong understand of 21 CFR part 11
• Annex 11
• USP 1058
• GxP regulations
• Abel guide site personnel in CSV topics
• Risk Assessments

If this sounds like the position for you then please apply today!





 




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