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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