Requirements: English
Company: RED Global
Region: Poitiers , Nouvelle-Aquitaine
A leading global pharmaceutical company is seeking a highly skilled QC Instrument Systems Expert to support and maintain critical business systems in the Quality Control domain.
This mission focuses on the maintenance and evolution of QC core models for microplate reader systems (SoftMax Pro) and Endotoxin testing platforms (Biomerieux, Lonza). The role involves collaboration across global teams to ensure compliance, efficiency, and alignment with GxP requirements.
Key Responsibilities:
- Support version upgrades and releases of QC systems including SoftMax Pro and the Endotoxin testing model.
- Prepare and update User Requirements (URS), ensuring data integrity and functional alignment.
- Contribute to documentation such as validation plans, functional specifications, risk assessments, and traceability matrices.
- Plan, coordinate, and execute User Acceptance Testing (UAT).
- Assist local sites in defining and fulfilling validation requirements.
- Develop and maintain SOPs, training materials, and user documentation.
- Organize and lead cross-functional meetings to gather user needs, share strategies, and provide business support.
- Act as a point of contact for user queries, deployment support, and quality events.
Key Skills and Qualifications:
- Expertise in microplate reader software, specifically SoftMax Pro by Molecular Devices.
- Solid knowledge of GxP-regulated QC environments and Endotoxin testing systems.
- Proven experience in Computerized Systems Validation (CSV).
- Proficiency with ALM, JIRA/Xray, and related tools.
- Strong communication and coordination skills across diverse, international teams.
- Fluent in English; proficiency in French is a plus.
Deliverables include:
- Leading User Communities and Core Team Meetings
- Documentation of validation lifecycle and release cycles
- Support for audits, CAPAs, and quality events
- Training and knowledge transfer to key users and stakeholders
If you are passionate about digital quality systems, thrive in regulated environments, and enjoy working in cross-functional global teams, we invite you to apply for this mission.