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Gxp Qualification Manager

3 months ago

Toronto, Ontario, Canada SAP Full time

We help the world run better


SAP Enterprise Cloud Services (ECS) is looking for a GxP Qualification Manager to support all aspects of the GxP regulated industries.

You will be working as a 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.

This also includes the oversight on other related GxP and CSV Framework topics.

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
  • Support of approvals for GxP profiles
  • GxP Training Management support
  • GxP consulting activities with regards to GxP Customers / will have customer contact

Experience / Role Requirements:

  • Advanced knowledge about GxP and CSV activities, especially in IT
  • SAP product experience of 2 years in a similar function with focus on processes and IT operations
  • Working experience with quality processes and standardization, in regulated environment
  • Knowledge of pharmaceutical, food and drug industry specifics
  • Advanced communication and documentation skills
  • Creative, reliable and strong focus on quality
  • Basic knowledge in ITIL (foundation certification) / ITSM processes
  • English fluent; French desired
  • Bachelor's degree, MBA or advanced degree in related discipline

Meet your team
SAP Enterprise Cloud Services (ECS) is delivering RISE with SAP with our customers. ECS provides a private cloud platform, infrastructure and managed services focusing on fast time-to-value to enable the Intelligent Enterprise. You will be part of a globally growing team.

SAPECSCareers #SAPInternalT3

We build breakthroughs together

We win with inclusion


SAP's culture of inclusion, focus on health and well-being, and flexible working models help ensure that everyone - regardless of background - feels included and can run at their best.

At SAP, we believe we are made stronger by the unique capabilities and qualities that each person brings to our company, and we invest in our employees to inspire confidence and help everyone realize their full potential.

We ultimately believe in unleashing all talent and creating a better and more equitable world.

EOE AA M/F/Vet/Disability:


Qualified applicants will receive consideration for employment without regard to their age, race, religion, national origin, ethnicity, age, gender (including pregnancy, childbirth, et al), sexual orientation, gender identity or expression, protected veteran status, or disability.


Requisition ID:
|

Work Area:
Information Technology |
Expected Travel: 0 - 10% |

Career Status:
Professional |

Employment Type:
Regular Full Time |

Additional Locations:
#LI-Hybrid