DirecciónDescripción del trabajo
Job Description
Main responsibilities will include :
- Plan and deploy the Global Quality Requirements at plant level
- Ensure that the processes and products in their scope are aligned with the Plant Quality Systems
- Participate in the validation of each product in their scope and other processes.
- Define control plan (In Process Control, Final Inspection) in production based on BD requirements
- Review and analyze quality data trends
- Lead the development of validation strategies and ensure their progress
- Follow up and resolution of non-conformances
- Project transfer activities
- Implement and ensure the data integrity of manufacturing processes
- Lead the CAPA process and ensure issue resolution
- Lead improvement projects
- Train the local operational team on product trainings
About you
Academic Background
Engineering degree
Valuable Complementary Training
- Master’s degree in Quality Management or Science
- Knowledge of Process Validation, Design Control, and experience in FMEA / Risk Management
- Understanding of industry regulations / standards : ISO, GMP, 21CFR
- Microsoft Visio and Project
Languages :
Fluent English
Previous Experience :
- Minimum experience of 3 years in a Quality Engineer role in industrial environments
- Validations in a regulated industry (Healthcare / Pharmaceutical / Biologics / Medical Devices)
- Project management
- ISO Management Systems ISO and system / process audits (internal and external)
- Standardized continuous improvement methodologies (PDCA, 8Ds, Lean tools ).
Hace menos de 1 hora
