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IT Quality Assurance Manager H/F

22 septembre 2017 CDI Boulogne-Billancourt - 92

Management : Non renseigné
Référence : CA/IQAM/92B/2024752

IPSEN

Purpose of the position :
- Manage validation activities in projects under his/her scope.
- Ensure maintenance in validated state for systems in his/her scope.
- Provide CSV expertise and support to IT teams.
- Contribute to improvements of the Quality Management System.

Main responsibilities and tasks.

Manage validation activities :
- Assess system risks and criticality.
- Determine validation strategy and deliverables.
- Review and approves validation deliverables.
- Coordinates validation activities.
- Guarantees validation status for Go-live.

Ensure maintenance in validated state :
- Ensures system is maintained according to requirements and processes.
- Performs impact analysis.
- Ensures appropriate change management on systems, review and approves action plans.
- Performs system reviews and audits.
- Guarantees traceability through system lifecycle.

Provide CSV expertise and support :
- Assist project teams on validation activities and deliverables.
- Provide support on validation packages during audits & inspections.
- Ensures inspection readiness on systems.

Contribute to improvements of the Quality Management System :
- Proposes or leads improvements on process and practices in the scope of validation and IT QMS.
- Contributes to or leads IT QMS and Global Quality projects.
- Ensure CAPA follow-up.

Experience / Qualifications :
- 6+ years experience in IT Computerized systems validation in a pharmaceutical or medical device environment.
- Knowledge of Pharmaceutical or Medical device regulations.
- Knowledge of SaaS systems validation processes.
- Knowledge of IT Infrastructure qualification.
- Certification in Audits is a +.
- Languages : English and French.

Technical Competencies
- Quality Management Systems.
- Computerized Systems Validation.
- Pharmaceutical regulations (FDA, Eudralex).
- SaaS supported systems.

- Good communication in transversal environments.
- Customer focus, agility, negotiation and result-oriented.
- Strong execution monitoring skills.

Internal and external contacts (organisation) :
- IT teams.
- Business systems owners / Key users.
- Contractors.

Rémunération : Non précisé.


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