computer system validation 91398

View: 135

Update day: 26-11-2025

Category: IT - Software IT - Hardware / Networking Information Technology Executive management Mechanical / Technical Maintenance

Industry: HR personeel

Job type: Freelance

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Job content

You are seeking a new challenge in Computerized System Validation (Computer Quality and Compliance)

You are an expert in MES/LES and/or SAP systems and you have a previous experience in Pharmaceutical Industry ?

You may be interested by our offer below !

Feel free to contact me : julie.licoppe@professionals.randstad.be

qualifications

education/knowledge/previous experience/skills :

strong knowledge in it quality assurance and computer compliance demonstrated through management of projects in this area
mes and/or sap knowledge
significant experience in computer system validation is mandatory
expert knowledge of appropriate regulations including cfr, eudralex, and industry publications such as gamp, ich, pic/s
good knowledge in good manufacturing practices and quality management system (qms)
ability to summarize, write and present technical subjects to senior management
fluent english (written and spoken)

key responsibilities

job purpose :

ensures computerized system are validated and that all external and internal validation requirements are met
ensures that validated computerized systems remain validated throughout their life cycle

key responsibilities :

acts as qa authority in the assigned area of responsibility (specifically manufacturing execution system mes)
drive adherence to computer quality & compliance policies and guidelines
reviews and improves computerized system validation (csv) documents and ensures adherence to internal and external guidelines
is involved in the creation and approval of major documents like validation plans and reports
ensure qa requirements for it systems are covered
share expertise and knowledge to provide input to project teams and global functions
support, communicate and follow-up on key quality issues related to computer compliance
participate as subject matter expert for compliance in team meetings where necessary to ensure adequate representation of computer compliance issues for discussion and escalation

key benefits

consulting mission until 24/12/2021 (renewable)

we offer an attractive salary with extra-legal advantages:

a rate as freelance is also possible

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