As a CI Specialist within our Quality team, you will contribute to ensuring the compliance and performance of critical equipment and processes at the Le Trait site, by piloting validation strategies in a sterile and injectable environment
Job Summary
As a CI Specialist within our Quality team, you will contribute to ensuring the compliance and performance of critical equipment and processes at the Le Trait site, by piloting validation strategies in a sterile and injectable environment.
Define and implement validation strategies for critical site equipment: autoclaves, gamma irradiation, electron beams (e-beam), isolators, cleaning and aseptic filling processes.
Benefit from attractive advantages: comprehensive health coverage, flexible working arrangements and well-being programs.
Matching Summary
As a CI Specialist within our Quality team, you will contribute to ensuring the compliance and performance of critical equipment and processes at the Le Trait site, by piloting validation strategies in a sterile and injectable environment.
Skills & Requirements
Must-have
Validation strategies for critical equipment
IQ/OQ/PQ protocol execution
cGMP compliance
Sterile and injectable process validation
Regulatory inspections and audits
Nice-to-have
Positive and motivating work environment
Collaboration with project teams
Continuous learning and development
Key Requirements
Experience in equipment/process validation in pharma/biotech