Job Description Purpose of the job :
Provide scientific and technical expertise in Microbiology methods, measurements and metrics as well as in aseptic processes
Supervise microbiological laboratory data and carry out trend analysis of environmental monitoring data
Propose and monitor implementation of appropriate corrective actions, assessment of alert levels and of overall status of bioburden control of the facility and personnel working in the facility
Support process simulations, assess aseptic practices of personnel working in the manufacturing facility.
Provide basic microbiology training and aseptic practices training to production personnel
Deliver technical support to the development and execution of microbiological methods such as Microbial Enumeration, Sterility in a barrier isolator, Endotoxin, Container Closure Integrity and non-
routine microbiological assays and applicable GMPs & laboratory techniques.
Supervise maintenance / troubleshooting of laboratory equipment.
Author microbiology SOPs and scientific & technical protocols and reports. Communicate results to QC Head and other functions as required
Perform laboratory investigations related to Deviations, OOS, and take part in change control processes.
Ensure accuracy & scientific soundness of Lab Data
Skills, experiences and qualifications required for the job : Education : BS /
Experience : Experience
Required : Desirable
Able to perform systematic problem solving
Tidy, neat and organized. Attention to detail
Must be able to work as part of a team but also have the confidence to work alone.
Good interpersonal skills
Flexible working attitude, open to changes for assuming new methodologies and activities.
General experience working with computers at user level, including MS Word, MS Power point and MS Excel.