The job is a great opportunity to develop your professional career in the team Validation of our manufacturing Plant.
You will support validation activities for Product Development department.
You will act as a Quality Validation representative for projects that include validation :
- Define the validation methodology and approach for the project in compliance with local procedures, Corporate and Industry requirements.
- Provide validation expertise and quality assurance guidance for the development of the project : direct involvement in the definition of the procss/system specifications.
- Participate in the risk assessment related to the project.
- Participate in the determination of process or system controls.
- Review and approve as Final Quality Approver the protocols, reports, tests sheets and non-conformities.
Finally you will ensure the follow-up and tracking of the validation’s activities and update the validation documentation system
Who you are
Pharmacist or Engineer with minimum experience of 5 years in Validation
Good knowledge of current European and FDA regulations
Excellent communication skills
Good problem solving and critical thinking skills
Good knowledge in statistical analysis
Good knowledge of English
Versatility, autonomy, rigor and reactivity