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What We Require
If you are a CSV consultant, engineer, specialist or subject matter expert and you have experience in some or all of the following;
GAMP lifecycle methodology (ISPE GAMP5)
Risk-based approach to validating GxP systems
Data Integrity and understanding of the ALCOA+ principles
Qualification of IT infrastructure
Understanding of Computer Software Assurance (CSA) and how this fits with CSV
Application of 21 CFR part 11
Please send a copy of your latest CV to csv@aaltix.com
Application of Annex 11 and Annex 15
Analytical equipment qualification and validation
GxP IT systems (such as LIMS, CDS, WMS, eQMS) qualification and validation
Application of ISO-13485 and ISO-14971
EU MDR and IVDR
Project Management and leadership skills of implementing validated systems
Alternatively, if you are looking for a career in CSV whether that is permanent staff or contract and you do not have the long list of requirements above, we would still like to hear from you. Once, we too were in your position!
Please send a copy of your latest CV to careerincsv@aaltix.com
1
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2
Prepare
3
Interview
4
Get Hired
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