IT Technology Consultant (f/m/d) - GxP Qualification Manager
Sybase
Bucharest, RO
2 zile în urmă

COMPANY DESCRIPTION

SAP started in 1972 as a team of five colleagues with a desire to do something new. Together, they changed enterprise software and reinvented how business was done.

Today, as a market leader in enterprise application software, we remain true to our roots. That’s why we engineer solutions to fuel innovation, foster equality and spread opportunity for our employees and customers across borders and cultures.

SAP values the entrepreneurial spirit, fostering creativity and building lasting relationships with our employees. We know that a diverse and inclusive workforce keeps us competitive and provides opportunities for all.

We believe that together we can transform industries, grow economics, lift up societies and sustain our environment. Because it’s the best-run businesses that make the world run better and improve people’s lives.

Summary & Role Information :

Summary :

As an IT Technology Consultant all aspects of the GxP regulated industries are your mission. You will be working as Qualification Manager and ensure compliance towards the standardized GxP Framework within the different teams working for GxP customers, during GxP System Setup, GxP System Operations and GxP System Decommissioning.

The Role :

  • Creation of Qualification Plans and Reports and circulation for signatures
  • Review of Installation Qualification and other GxP related documentation
  • Allocation and tracking of open deviations
  • Support creation of GxP documents and related tasks during GxP system provisioning
  • Creation and circulation of GxP System Decommissioning documentation
  • Conduct Periodic Reviews
  • Audit support
  • Experience :

  • Bachelor's degree in Business Administration, Engineering or Computer or Natural Science required from an accredited university, MBA or advanced degree in related discipline
  • Basic knowledge in ITIL (foundation certification) / ITSM processes
  • English fluent
  • Expertise of working in multi-national teams and project environment
  • SAP product experience of 2 years in a similar function with focus on processes and IT operations
  • Previous experience with quality processes and standardization
  • Working experience in a regulated environment
  • Knowledge of pharmaceutical, food and drug industry specifics
  • Advanced Knowledge about GxP
  • Advanced communication and documentation skills
  • Creative, reliable and strong focus on quality
  • About the team :

    Enterprise Cloud Services (ECS) Delivery is delivering HANA Enterprise Cloud (HEC) services for external customers with strong market driven requirements in a highly dynamic working environment.

    You will be part of a global expert team.

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