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Job title : Global M&S Services, Manufacturing & Supply Quality - Business Expert

• Location: Budapest, Hungary

About the job

In the frame of Quality transformation & digitalization, contribute to the execution of Digital Projects as Business expert in agile mode, including accountability for appropriate & compliant design of simplified and standardized processes defined by relevant Business Process Owners, manage planning, quality of the delivery, compliance, and excellence in execution at shopfloor level (site, affiliate, entity).This also includes compliance of the digital solution upon design, deployment and all along life cycle management.

Under the supervision of the Global Solution Lead, and the umbrella of the program lead, contribute to the delivery (build, deploy and support to routine usage) of M&S Quality digital capabilities (related to serialization, secured Batch release & shipment to Market, eBatch release protocol towards heath authorities, Batch traceability & genealogy, digitalized forms at shopfloor manufacturing & warehousing).

Your job, as Global M&S Services, Manufacturing & Supply Quality - Business Expert will be :

Main responsibilities:

• Contribute to project execution & successful delivery of compliant global digital quality solutions for Global Quality in alignment with the defined strategy and process designed (adherence to prescribed process, user stories scripting, risk assessment, UAT scripting & execution, defect management, training material delivery, user adoption & support along life of the system)

• Contribute to the implementation of a clear and consistent approach to manage project risks, progress and delivery

• Ensure close collaboration with digital teams & partner solutions / teams as needed

• Support the transformation of processes and ways of working associated with the project under his/her responsibility.

• Contribute to user adoption, and support end users in daily operations (trouble shooting, escalation of quality events…)

• Coordinate and ensure consistency of usage (across organizations/GBUs) in adequation with real needs and process design

• Ensure Life cycle management & compliance along time (deviation management, incidents solving, change control, etc..) in liaison with BPOs, Global Solution business owner and digital teams

• Contribute to value realisation through the implementation & usage of the new solution implemented. Support measurement of the impact of the solution implementation through relevant KPIs defined with Performance team and the relevant BPOs

About you

Experience :

• Manufacturing & supply shopfloor processes knowledge & experience (serialization, batch release & secured shipments, traceability & flows, maintenance & calibration, cleaning …)

• Significant experience in digital projects in agile mode and in pharmaceutical Manuf & Supply and quality areas

Technical skills :

• Rigorous in an agile working environment,

• Ability to communicate, deliver & report

• Action & result oriented. Team player

• Pronounced appetite for digital & data

• Solid knowledge & experience of computerized systems GxP requirements & validation and in Data Integrity

Education :

• Technical/scientific education, data management

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.

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