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Csv Expert
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Overview:
**Responsibilities**:
Participate to projects follow-up meetings and schedule appropriately CSV activities related to new equipment/systems to be qualified/validated
Schedule appropriately CSV activities related to periodic evaluations of already qualified/validated systems
Is involved and participates early in projects launching and gives input regarding pre-requisites needed for CSV activities
Write and/or review of the qualification / validation documents related to CSV activities (URS, risk analyses, protocols, reports,) for production and QC equipment
Execute CSV testing on production and QC equipment
When appropriate, manage, write, investigate and follow up of deviations related to CSV topics.
When appropriate, write SOP or work instructions related to CSV activities.
When appropriate, gives input related to CSV status of equipment/systems during updates of the DVP’s of the different production and QC entities
Act as an SME during authorities and customers inspections/audits for CSV topics
Be able to find the correct balance between quality, output, safety and cost.
Follow training as needed to fulfill function requirements
Actively participate in continuous improvement of plant activities
Qualifications:
Minimum 5 years in CSV process control
Knowlegdee in:
- Project management
- Periodic review
- Change management
- CSV assessment
- Automation
- GMP (Eudralex) annex 11 et 15, 21 CFR Part 210-211, GAMP5, 21 CFR Part 11.
Languages: English, French