Specialist -Quality Control (Microbiology)

KEY DUTIES AND RESPONSIBILITES:

. Responsible for the analysis of RM, finished product/in-process/stability/validation/utility samples for MLT by referring current version of specification/STP/SOP with relevant product code.

. Responsible for the analysis of water samples by referring current version of specification/STP/SOP with relevant code, based on of monthly schedule.

. Responsible for the analysis samples of EMP by referring current version of SOP.

. Perform identification of microorganism isolate by microscopy.

. Perform the assay test as per STP/SOP by Microbiological method.

. Check the sample integrity with respect to labelling, container, packing, time point, sampling point, etc., along with availability of reagent/chemical/media as per STP/SOP and within the validity.

. Preparation of all microbiological media/diluent/sample as per SOP/STP.

. Ensure maintenance, review and availability of media/cultures and miscellaneous materials.

. Ensure implementation of SOP for all corresponding activities.

. Write controlled documentation related to Microbiology Laboratory operations or testing such as SOP's, analytical protocols, analysis reports and forms.

. Ensure real time documentation, maintain data integrity and appropriate traceability.

. Responsible for checking all results in LIMS/RDS and reporting of any observed results that do not meet the requirement (OOS/OOT/Deviation) for further investigation.

. Responsible for preventive maintenance and calibration of microbiological lab instrument.

. Responsible for microbiology lab and equipment/instrument cleanliness.

. Responsible for procuring and receipt of microbiology lab glassware and consumables.

. Preserve all sample media petri plates till the completion and confirmation of results.

. Responsible for disposition of samples upon confirmation.

.Any other activities as and when assigned by the Superior.