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Consultants

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

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