Data Integrity Engineer

Kantoor: 
Sanofi
Referentie: 
1463087
Jobtype: 
Vast contract
Contract type: 
Bediende
Functieomschrijving: 

Position Title
Quality Engineer - Data Integrity Champion

Departement Description
Quality – Digital Systems (Sanofi Geel)

Job overview

The Data Integrity Champion is the end-to-end service owner for compliance readiness of computerized systems/equipment and data integrity
You will work closely with all departments and Quality management to address any data integrity issues related to management of demand, logistics, escalation, and continuous improvement. 
You will be the chair of data integrity steering committee and member of global COP.

Key Responsibilities

- Define and implement the strategic approach to site-wide data integrity assurance.
- Responsible for management of audit / inspection events impacting systems & processes and support of departments for GxP events or inspections involving CS compliance and data integrity. 
- Direct, develop and maintain Data Integrity compliance activities for the site and applicable support processes to ensure alignment to corporate and regulatory requirements

Profiel: 

Required skills & Qualifications

- Master’s degree in engineering or scientific discipline - healthcare industry specialty is desirable 
- You have 5+ years’ experience in a pharmaceutical production environment and experience with CGMP regulations.
- You have experience in following disciplines:
*audit & inspection management (SME and auditor role)
*compliance and validation of computerized systems
*data integrity assurance
*Risk managment
*Planning
- You have good communication skills/stakeholder management (Dutch and English)
- You have strong ‘technical writing and documentation skills’ (Dutch and English)
- You work result-oriented, flexible and you can make decisions

Aanbod: 

Als Data Integrity Engineer kan je rekenen op onderstaande aanbod:

Sanofi Genzyme biedt een fulltime functie met verantwoordelijkheid in een brede groeiende organisatie waar betrokkenheid, integriteit, ondernemingszin en samenwerking drijvende waarden zijn.

  • Extra legale voordelen:

    • Maaltijdcheques: €8/dag
    • Ecocheques
    • Hospitalisatieverzekering via DKV
    • Deelname in het bonussysteem
  • Onmiddellijke indiensttreding
  • Doorgroeimogelijkheden
  • Opleidingen
  • Bedrijfsrestaurant