- Independent, timely and cGMP-compliant execution and documentation of analyzes in accordance with the testing monograph, analysis methods, approved test methods or specific test protocols (non-routine).
- Timely execution and deadline monitoring of test orders
-Control of raw data, entry of results in SAP, creation of analysis results and analysis reports
- Support in clarifying Out of Expectation (OOE) / Out of Specification (OOS) results. Opening and processing of OOE / OOS / Analytical Deviation investigations including the implementation of analyzes as part of the clarifications.
-Ensure that the associated GMP, safety and ecological guidelines are adhered to in all work, compliance with the regulations (cGMP, SOPs, HSE regulations, team rules)
- Independent processing of special orders and AS&T internal projects
-Acceptance of laboratory samples and preparation of inspection lot orders
-Support of the laboratory team for an optimal (efficient) sample analysis
-Support of the laboratory team for a timely and optimal preparation and implementation of samples for the area of cleaning validation / verification.
- Care, operation and maintenance of equipment, aids and facilities
- Help with the qualification of analytical instruments and systems including documentation in the area of responsibility. Ensuring the correct and timely calibration of the analytical instruments and systems in the area of responsibility
-Transparent and proactive communication of work progress and plan deviations
-Support of the team with any analytical, scientific or technical questions
-Active support and compliance with laboratory processes as part of day-to-day business
- Role model for the group in terms of values and behavior
The following background for the position would be ideal:
* Training as a laboratory technician or equivalent training
* Work experience in a GMP environment
* German, spoken and written / English is an advantage
* Analytics laboratory assistant in a GMP environment
* In-depth knowledge in the area of HPLC or other pharmaceutically relevant analytical techniques
• Knowledge of working with Office applications
Languages: German and English
Michael Bailey International is acting as an Employment Business in relation to this vacancy.