Specialist - Quality Control (Micro) - #1126887

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 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. 

COMPLIANCE AND QUALITY:

• Good understanding of safe working practices and cGMP.

• A good team player with positive learning attitude.

• Microsoft savvy with good interpersonal skills.

EDUCATION & EXPERIENCE:

• Degree / Diploma in Science related discipline.

• Minimum 4 years of experience in a pharmaceutical environment.