Quality Engineer Process Automation (CAPA)

Job Title: Quality Engineer Process Automation
Job Type: Contract
Location: Puurs, Belgium
Languages : English and Dutch

Project Description / Scope of work:
• Responsible for follow-up of CAPA / CRF / MIR / PR
o Responsible for performing Root cause investigations
o Contact point for Production Support / Engineering / QA Operations for follow-up of corrective actions, changes and deviations
o Take the necessary steps as coordinator to get action items closed in time and you involve all necessary parties
o Responsible for performing Periodic Review of all computer systems
• Responsible for coordinating validation in projects
o Determine the validation approach and write validation plans / reports
o Project engineers coach where necessary in validation
o Perform risk analyzes
• Actively participate in the Quality Support team
o Participate in team meetings and develop the Quality Support team
o Active participation in system teams including Engineering Quality team (EQT)
o maintain good contacts throughout the entire organization and develop your network according to your tasks
o Develop systems / processes to support the roles and responsibilities of the team

Soft skills:
• Industrial, civil or bio-engineer with a strong interest in software development and technology
• Be able to work in a highly structured manner
• Good technical writer skills
• Adapt communication style to each level of the organization
• Strong communication skills
• Strong analytical power
• Problem solver
• Born team player
• Being able to work independently
• Can deal with changing priorities
• Good knowledge of Dutch and English

The consultant ends up in an environment with innovative solutions and will work in line with quality requirements and GMP requirements