Internship: Quality Engineer (Data Integrity Champion)
Sanofi
Geel, België - Belgique - Belgien
4 dagen geleden
source : Wizbii

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
  • 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
  • Offer

    Sanofi Geel offers a full-time position with responsibility in a growing organization where involvement, integrity, entrepreneurial spirit and cooperation are driving values.

  • Fringe benefits : Meal vouchers / Eco vouchers / Hospitalization insurance DKV / Participation in the bonus system
  • Open-ended contract
  • Training programs
  • Company restaurant
  • At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers.

    We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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