Tasks

- Supervision of the QC transfer group and coordination of the transfer-/validation activities for raw materials
- Creation and review of transfer-/validation protocols and reports according to internal and international guidelines (EP, USP, ICH…)
- Responsible for troubleshooting concerning analytical deviations as well as deviations regarding the laboratory
- Creation and review of SOPs, CAPAs and Changes
- Creation and review of qualification and calibration documents for laboratory devices / laboratory systems
- Presentation of the progress of the transfer-/validation activities in international meetings

Qualifications

- Completion of a university degree in chemistry with several years of professional experience
- Well-founded GMP experience and good knowledge of instrumental analysis (HPLC, GC and Particle Size Distribution with Mastersizer 3000)
- Profound knowledge in the validation of methods or in their transfer and verification according to USP and additionally in the qualification of laboratory equipment
- Leadership experience is an advantage
- Good spoken and written German & English knowledge
- Good knowledge of IT (MS Office etc.)
- Knowledge of the use of a CDS and a LIMS is an advantage
- Knowledge of Lean Management for Laboratory Excellence programs is desirable