This position is responsible to perform all type of analytical testing that is required for release of raw and packaging materials, final product and stability samples as well as all IPC testing. Additional responsibilities can be the support of stability studies, handling of deviations and change controls. As a QC team member, the person filling this position supports all activities to continuously maintain the GMP status of the QC Laboratory.
- Performs analytical testing according to raw material and product release specifications (HPLC, GC, UV/VIS, IR, dissolution, pH, conductivity, TOC, titration, weighing, wet chemistry experiments etc.).
- Performs review of analytical data.
- Performs basic laboratory work (buffer preparation, waste disposal management, washing of lab dishes, cleaning of the labs etc.)
- Supports management supply of consumables.
- Supports maintenance/calibration of equipment and keeps relationship with suppliers.
- Supports stability studies (set up, sampling, testing, coordination)
- Writes specific standard operations procedures (e.g. operation and maintenance of equipment)
- Participates in method transfer and method validation activities
- Supports selection, purchase and commissioning of new equipment.
- Handling of deviations and change controls k. Can be assigned special tasks and project work
- Good writing skil
- Excellent team spirit.
- Good knowledge in English and French
- Knowledge of most common office software
Key technical competences required
GMP Good manufacturing practice
QC Quality Control
HPLC High Performance liquid chromatography
GC Gas Chromatography
IR Infra Red
CDS Chromatography Data System
TOC Total organic carbon
Ph. Eur. European Pharmacopeia
USP United States Pharmacopeia