Our Client in Switzerland is an international leading Biotechnology company which are in the process of building their new state of the art manufacturing facility.
They are urgently looking for a Quality Control Analytical Associate Microbiology for a short term project (4 months)
- Do you have a scientific background?
- Experience with microbiological analytical methodologies and testing?
- Have you worked in a GMP environment before?
Then you are the ideal candidate for this position!
The main responsibilities for the Quality Analytical Associate III Microbiology will include execution of all of the Microbiology related testing activities at the clients new large scale manufacturing facility in Solothurn, Switzerland. The Quality Analytical Associate III will also be accountable to support the proper IQ / OQ / PQ of instrumentation and method validation in alignment with the client and Industry standards. Microbiology related analysis at the site will include: microbiological identification, bacterial endotoxin test (kinetic-chromogenic), detection of microorganisms (BacT/Alert) and microbial enumeration test. Additional tests will include Total Organic Carbon and conductivity. Automated/rapid as well as traditional methods will be applied. As the facility is being finalized for drug substance production, the Quality Analytical Associate III will support the facility certification with respect to the environmental monitoring (EM), utility monitoring (UM) and compressed gas distribution validation.
- Techniques to be performed in the central laboratory will include growth promotion test, microbial enumeration of in-process and EM/UM samples, Bacterial Endotoxin Test (kinetic-chromogenic) and microbiological identification.
- The Quality Analytical Associate III should have a strong background in microbiological analytical methodologies.
- The Quality Analytical Associate III is expected to become a technical expert for classical and rapid methods and its instrumentation.
- The Associate has to correctly work with cGMP regulated computerized systems which are necessary for the testing workflow as these systems will support the vision of establishing a paper-less lab and ensure the relevant data integrity.
- The Quality Analytical Associate III will support the Microbiology Team with establishing analytical procedures and protocols related to microbiological analysis.
- IQ / OQ / PQ of instrumentation and method validation
- microbiological analytical methodologies and testing
- Fluency in English is required
- Team player
Ulrike De Smedt
+32 15 21 11 04