Laboratory Software Validation Expert

Job type:
on-site
Start date:
ab sofort
Duration:
7 months
From:
Location:
Brüssel
Published at:
05/20/2020
Country:
flag_no Belgium
Contact person:
Pascal Freyer
Project ID:
1930010

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For one of our Belgian clients we are seeking freelance support as:
Laboratory Software Validation Expert (M/W/D)
 
Tasks:
· Performs validation activities and deliverables on Changes and small Projects in GxP and GLP environments
· Lead, in time and manner, Retirement Plans and execution exercise in collaboration with stakeholders (ITSO, PDO, Compliance…), manage defect(s) in alignment
with stakeholders
· Provide support for system Periodic Review
· Escalate to the IT Compliance Lead
· Write test scripts (IQ/OQ), support creation of PQ, create protocols and report
· Coordinate test execution in collaboration with ITSO, PDO and testing team
· Possibility to participate to a GLP lab automatization project in collaboration with other IT Validation Analyst
· Inspection/Audit preparation and defense
· Weekly review meeting with associated IT Compliance Lead
 
Qualification:
· +3 years CSV experience on various projects in GLP and lab standalones/equipment scope
· Previous experience in GLP lab automatization is a +
· Knowledge on Validated R (R applications), ICE3, laboratory standalones and equipment
· Testing knowledge
· Must have: Business fluent in English
· Nice to have: French
 
Frame Data:
· Start: asap
· Duration:
· Capacity: fulltime