Quality Consultant/Freelancer
Discover International, New Bremen, OH, United States
Please note that this is a hybrid/on site role in Germany
Technical handling of selected deviations, including root cause analysis, as well as advising on the definition and follow-up of CAPAs
Project-based support in CAPA and complaint management in an advisory capacity
Creation, review and optimisation of SOPs and GMP documents within the scope of defined projects
Conducting risk assessments (e.g. FMEA) and deriving technical recommendations for corrective actions
Design, preparation and technical delivery of GMP training as an external training service
Technical review of manufacturing and testing documentation
Advisory support to departmental management on clearly defined GMP and optimisation projects
Requirements
A degree in a natural science subject or comparable qualification is desirable
At least 5 years’ experience in a GMP-regulated environment
At least 3 years’ experience in solid dosage form manufacturing
In-depth knowledge of deviation and CAPA management as well as GMP regulations (EU-GMP)
Structured, independent and solution-oriented approach to work
#J-18808-Ljbffr
Technical handling of selected deviations, including root cause analysis, as well as advising on the definition and follow-up of CAPAs
Project-based support in CAPA and complaint management in an advisory capacity
Creation, review and optimisation of SOPs and GMP documents within the scope of defined projects
Conducting risk assessments (e.g. FMEA) and deriving technical recommendations for corrective actions
Design, preparation and technical delivery of GMP training as an external training service
Technical review of manufacturing and testing documentation
Advisory support to departmental management on clearly defined GMP and optimisation projects
Requirements
A degree in a natural science subject or comparable qualification is desirable
At least 5 years’ experience in a GMP-regulated environment
At least 3 years’ experience in solid dosage form manufacturing
In-depth knowledge of deviation and CAPA management as well as GMP regulations (EU-GMP)
Structured, independent and solution-oriented approach to work
#J-18808-Ljbffr