Responsible for the lab work during process development and/or quality control. Role focus can be either on process development support (Analyst non-GMP) or on support of drug substance supply and analytical method lifecycle (Analyst GMP).
- Performs analytical experiments in the lab according to GMP, ICH/Health Authority (HA) and HSE regulations and risk assessments as required.
- Documents the lab work in appropriate form following good documentation practices
- Performs experiments in the lab according to instructions.
- Performs experiments in the lab fully independently
Minimum: Laborantenausbildung or equivalent
Good skills in site (local) language is necessary (oral and written). English at least basic skills (read and understand)
- Exact and efficient laboratory work and documentation practices (also under GMP where required).
- Good technical know-how of standard lab equipment
- Software know-how