IT Quality Systems Expert

1 day ago

India Merck Full time ₹ 30,00,000 - ₹ 60,00,000 per year

As part of the global Quality, Governance and Compliance unit of SUSONITY, we are managing the IT quality systems like document-, training-, audit-, and deviation management systems (e.g. ManGo, TrackWise/Interlex or SALA) within SUSONITY. We are acting as an interface between our commercial units and corporate functions like IT, focusing on supplying a constantly high and increasing level of quality of our systems and services.

Your Role

In your role as IT Quality Systems Expert, you will take over the business coordination as global lead user for our SALA IT solution for training management. Besides the lead user roles, which contain training and support of key users, you create and maintain related system-specific procedures (SOP's) and become the global expert for training management systems. Quality processes, like risk management, change control or deviation management, are familiar terms for you.

Furthermore, you will be the GxP expert within the new ERP project team, which is currently kicked off to implement a new ERP system within SUSONITY. In this role you develop and maintain test plans, test scripts and user acceptance test and manage the execution of test plans, validation plans and validation documents for GxP related tasks. You ensure initiation/preparation and closeout of impact on the GxP related changes.

In this position, you work with other global departments and sites to solve problems, improve service and to roll out enhancement projects within SUSONITY.

Who you are

  • Bachelor or master's degree in (business) computer sciences or equivalent
  • Software skills in training and/or document management systems
  • GxP expert and knows how to implement GxP requirements into complex IT-systems
  • Sound knowledge and experience in quality-related function and the ability to apply quality processes to IT systems operations
  • Good understanding of regulatory and compliance requirements in the context of electronic systems (data integrity, data retention)
  • Experience in computer system validation and GAMP is a plus
  • Ability to understand and communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks
  • Ability to lead & implement project initiatives
  • Curious about new technologies
  • Excitement about the SUSONITY business and joining a motivated, global and intercultural team
  • Fluent spoken and written English

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