Making A New Department From Within Sterility Assurance And Microbiology

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I would like to talk about a challenge which I faced at my present job. I work in quality control group of a pharmaceutical company making sterile injectable drugs. I was given the responsibility to start a new department from within sterility assurance and microbiology. The new department was given the responsibility of environmental monitoring of all the production areas. We aseptically fill different drugs in multiple filling rooms. Air in these and supporting areas is controlled by HEPA filtration and is positively pressurized. My department’s job was to monitor the air and surface quality of these rooms. We monitor both the non-viable (particles in the air) as well as the viable (microorganisms) particles in the air inside these…show more content…
In one of my previous job also, I was given a similar assignment and there I took sufficient of time to hire the best fits since there were not many candidates fitting the requirements. That delay in hiring delayed the start of the assignment, which was not liked by the upper management. Learning my lesson from that experience, I hired the required number of personnel within a short period. I trained them quickly and got them to work within a short period of time. Although, I hired them quickly to start the work but I found out after some time that few of them were not good workers. Since we were part of the quality control, I wanted the best quality out of all my folks but some of them were not up to those standards. I had to spend extra time to retrain them and teach them the concept of aseptic techniques and details about our sampling methods. I was able to bring most of them to those standards but two of them did not understand the process fully and were making lots of mistakes on a daily basis. They posed a big challenge for me since even after repeated training sessions; they did not understand the whole process. I did not want to let them go since both of them badly needed their job. As a solution to this issue, I assigned them less challenging work with lesser responsibilities, so that they make less

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