Pharma Data Integrity & Validation Consultant

QbD Group; Petit Pièrsoû; Presencial; EUR 65 000 - 85 000; Tempo integral

Resumo da oferta

QbD Group is seeking a Data Integrity & Validation Consultant to join a multidisciplinary team supporting a large-scale digitalisation program in the Life Sciences sector. The role emphasizes data integrity, ALCOA+ principles and validation of manufacturing systems, with close collaboration with operators and stakeholders.

You will map data flows, assess risks, and drive remediation actions while contributing to knowledge sharing and potential integration of QbD software at client sites.

Qualificações

• Master's degree in a scientific or engineering field.
• Solid knowledge of data integrity (ALCOA+, 21 CFR Part 11 / EU Annex 11).
• Experience with DI assessments, gap analyses or remediation is a plus.
• Able to analyse process flows and turn them into structured documentation.
• Experience in Life Sciences, manufacturing or production environments.

Responsabilidades

• Map and analyse process flows and data flows across manufacturing systems from data generation to reporting.
• Assess data integrity risks and identify gaps in controls such as audit trails and access management.
• Define remediation actions and translate findings into practical recommendations.
• Support validation and compliance of digital and automated manufacturing systems with data integrity as the guiding thread.
• Engage with operators and end users on the shop floor to gather real-world insights.
• Collaborate with QbD consultants and client stakeholders.

Conhecimentos

Data integrity

Process flow analysis

Life Sciences experience

PCS SCADA HMI

Siemens PCS 7

French fluency

English proficiency

Shop floor communication

Attention to detail

Project management

Adaptable

Formação académica

Master's degree in science/engineering

Descrição da oferta de emprego

QbD Group is seeking a Data Integrity & Validation Consultant to join a multidisciplinary team supporting a large-scale digitalisation program in the Life Sciences sector. The role emphasizes data integrity, ALCOA+ principles and validation of manufacturing systems, with close collaboration with operators and stakeholders.

You will map data flows, assess risks, and drive remediation actions while contributing to knowledge sharing and potential integration of QbD software at client sites.