Job title: GenAIR PQR Expert

• Location: Budapest, Hungary 
• Hybrid working

Our Position

The GenAIR PQR Expert support is in charge of supporting the Global Solution owner in leading the implementation, routine management, and optimization of GenAIR PQR solution supporting the Product Quality Review from the creation of the report to the review and approval. This role ensures standardized processes, effective data management, data integrity and value realization through solution design & implementation while maintaining compliance with applicable regulations related to PQR process & GxP regulations.

Context: GenAIR PQR

The role is responsible for activities related to the automation of PQR authoring through full digitalization. The objective is to support project initiatives to deliver the PQR by leveraging GenAI technology to automate all sections and approval workflows for the sites and entities impacted by the PQR process.

Solution design & test

Support Global Business Solution Owner Deliver User stories / functional specifications in liaison with Digital teams supporting the defined process

Tests & validation: ensure compliance of the solution in defining adequate risk based validation approach

Build demonstration of the validation status of the solution

Deliver training material, SOPs / Job aids to end users

Solution implementation

Support Global Business Solution Owner in driving effective deployment of the solution

Ensure consistent usage across organizations and adherence to data management rules.

Ensure adequate support to users

Lifecycle Management & Compliance

Ensure compliance throughout solution lifecycle.

Support user community through training and community animation.

Handle changes, trouble shooting and incidents escalation with digital teams and business partners at core solution level in liaison with Global System Owner and Process Owner.

Process Standardization

Contribute to standardization of processes and ways of working.

Coordinate usage consistency across organizations/GBUs aligned with process design and SOPs/job aids

• Experience:
  • 5+ years of experience in pharmaceutical industry
  • Hands-on experience in PQR process
  • Experience in digital / computerized systems in project mode

• Technical skills:
  • Proven experience in GxP regulated environments
  • Solid knowledge of computer system requirements & validation
  • Experience implementing digital solutions in GxP contexts
  • Ability to communicate, deliver & report
  • Action & result oriented
  • Pronounced appetite for digitalisation & data
  • Trouble shooting & anticipation
• Soft skills:
  • Good communication
  • Results-focused, problem-solving and proactive
  • Action-oriented, results-driven mindset with a focus on customer outcomes
• Education: Technical/scientific education, engineering (life sciences)

• Languages: Good level of Professional English (mandatory ++)

Why choose us?

• Within PTSO organization, the Quality Programs team is responsible to ensure the successful & compliant design and implementation of Quality Digital solutions supporting the strategic transformation of Quality operations, towards simplified, standardized & digitized processes.
• Our team is responsible to lead the quality digital transformation, managing digital projects and quality data. The scope includes all projects within the quality global function: Quality Management Systems, Quality control, Supply Chain & manufacturing as well as Analytics related projects.
• This includes the ownership of the solution and relative data for the Quality Function: structure and maintenance of the global quality data referential (QA/QC) and to advise on it’s appropriate and consistent usage across digital projects and processes. It covers KPIs & artificial intelligence use cases for Quality.

PursueProgress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

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