Lab Systems Coordinator (all genders)

Evotec; Colomiers; Sur place; EUR 45 000 - 75 000; Plein temps

Résumé du poste

Une entreprise innovante recherche un Coordinateur des Systèmes de Laboratoire pour son site de Toulouse. Dans ce rôle dynamique, vous serez responsable de la gestion de projet pour toutes les activités des systèmes de laboratoire QC, en veillant à ce que les livrables soient conformes aux exigences réglementaires et aux délais. Vous collaborerez avec des équipes internes et externes pour résoudre les problèmes de qualité et de livraison, tout en maintenant la conformité GxP. Si vous avez une passion pour l'amélioration continue et une expertise en gestion de projet, cette opportunité est faite pour vous.

Qualifications

• 8+ ans d'expérience en gestion de la qualité et de projet dans un environnement réglementé GMP.
• Certifications PMP et LEAN Six Sigma préférées.

Responsabilités

• Surveiller les horaires et les rapports pour l'équipement et les logiciels de laboratoire.
• Agir comme point de contact pour les demandes des clients en matière de contrôle qualité.

Connaissances

Gestion de projet

Compétences en communication

Analyse des données

Pensée critique

Compétences organisationnelles

Formation

Master en Biochimie

Master en Biologie

Master en Microbiologie

Master en Chimie

Outils

Microsoft Office

Systèmes de laboratoire GxP

LIMS

ELN

Description du poste

Lab Systems Coordinator

CDI/Permanent position

The Lab Systems Coordinator for Toulouse site reports to the VP Global Quality Control. This position is responsible for providing project management oversight of all Toulouse QC laboratory system activities, coordinating across functional areas to ensure that project and testing deliverables are fully compliant with the Just Pharmaceutical Quality System (PQS) and adhere to company and client timelines.

This role, as the QC laboratory systems coordinator, will partner to manage schedules, provide metrics and progress reports, and coordinate discussions to facilitate deliverable prerequisites.

Responsibilities

• Provide schedule oversight and reporting mainly for, but not limited to, new and existing laboratory equipment and software, analytical method transfer, routine test data reporting, and audit response.
• Act as relay of QC for the review and approval of qualification, validation, and procedural documents in an environment compliant with regulatory requirements and guidelines (ICH, CFR, FDA) as they relate to drug substance biological manufacturing and release/stability testing/method validation.
• Routinely report key metrics to senior management in support of tiered accountability and Quality Management Review meetings.
• Coordinate risk assessment and problem solving discussions using LEAN management tools in support of ongoing activities and future process improvement.
• Act as a point of contact for Quality Control client inquiries and cross-functional investigations, ensuring prompt communication and delivery.
• Understand JEB QC processes to ensure deliverables adhere to global and site procedural requirements and align with upcoming process changes.
• Partner with both internal/external collaborators, vendors, and regulatory agencies to anticipate and resolve quality and delivery issues as well as maintain GxP compliance.
• Train employees or sub-contractors in establishment and use of project management and metrics reporting tools.
• Travel to other JEB sites as required.

Qualifications

• Master Degree or + in Biochemistry, Biology, Microbiology, Chemistry, or a Scientific/Engineering degree.
• A minimum of 8+ years of relevant quality and project management experience in a GMP regulated environment (FDA and EMA).
• Project Management Professional (PMP) and LEAN Six Sigma certifications preferred.
• Strong computer skills including Microsoft Office and relevant experience with GxP laboratory systems including LIMS and ELN.
• Key competencies in verbal and written communication; attention to detail and organizational skills; data collection, management, and analysis; judgment and critical thinking.
• Fluent level of French and English both written and spoken.