Beschreibung
We are looking for a
Laboratory Head QC (m/f)
Reference: -en
Start: asap
Duration: 3 MM++
Place: in Hesse
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Analytical method validation leader (Quality)
- Define GMP SST criteria for the method
- Write GMP control test method
- Release GMP test data for validation and comparability (in case no QC lab head or team lead is available for that task)
- Define method validation strategy and write validation protocol
- Evaluate analytical validation results and write of validation report
- Define and write analytical comparability protocol
- Evaluate analytical comparability results and write comparability report
- Write adapted “analytical procedure” starting from GMP control test method
- Analysis of proteins and peptides by liquid chromatography and mass spectrometry (if possible)
Your qualifications
- Experience in cGMPs
- Experience in analytical validations and comparability studies
- Analytical CMC background
- Scientific background
- Organizational skills
- Fluency in English and German
Skills:
- Head of laboratory