Perform environmental controls and water-sampling throughout the plant, including the sterile production area.
1. Perform routine and batch related environmental controls in all production and related areas as:
- particle counting
- volumetric air-sampling
- exposure of settle plates
- testing of surfaces
2. Create LIMS(*) requests and to document environmental results in the LIMS system(*) = Laboratory Information Management System
3. Perform daily sampling on water (i.e.WFI, PW and CW) for further testing in the laboratories
4. Perform environmental controls and quality inspections during media-fill. Give feedback on observed practices and suggest improvements to production management
5. Initiate lab investigation reports when observing OOS results and assist the Senior-Analyst in performing OOS investigations/inspections
6. Read media-fills in inspection boxes
- Propose new or adapted equipment and instruments for the laboratory.
- Assist in problem solving
- Propose and initiate changes in SOPs
- Perform all activities according to cGMP guidelines.
- Read and handle pharmacopoeia and guidelines if necessary
- Execute various tasks assigned by supervision (e.g. special request testing, testing for validation, water analysis,…).
- Validate the generated environmental and water results, both routine and batch related in the LIMS system
- Responsible for peer-to-peer training.
- Responsible for the cleanliness in the lab according to the housekeeping program.
IMPACT AND PROBLEM SOLVING
The tasks of the Analysts are mainly operational tasks following the precise guidelines: complete the tests within the required periods according to the priorities set by the Supervisor or by production based on batch preparations. The tasks to be performed have limited diversity: routine and experience are used to solve the majority of problems