Microbiologist

Job Purpose 

The incumbent is responsible for conducting sampling and testing of water and environmental monitoring (facility), in-process product, final product, raw materials, primary packaging material and stability testing in accordance with procedures as well as conducting any special request microbiological testing as required.

Key Accountabilities

ANALYTICAL TESTING/ PRODUCTIVITY

To ensure the compliance with Good Laboratory Practices as laid down in the Quality Control procedures, relevant industry guidelines and regulations.

Initiation and completion of work allocated.

Follow the written procedures for environmental monitoring of Manufacturing areas and the Microbiology Laboratory as per schedule.

Carry out tests according to relevant Microbiological Testing Method

Sampling and testing of purified and potable water, compressed air and personnel. 

Execution of special request e.g. investigations as required by QA & cleaning validation studies.

Follow the written procedure for preparation of swabs, pouring of media plates and labelling of plates.

Ensure that the laboratory is fully stocked at all times and orders of laboratory consumables are placed as agreed upon by the Microbiology Supervisor/ designate.

Follow the written procedure for preparation, growth promotion testing, sterility and pre-incubation testing of media.

Follow the written procedure for maintenance of aseptic testing areas.

Calculation of alert and action limit for Environment monitoring, water, personnel hygiene and other routine monitoring activities.

Receipt, release and maintenance of prepared media stock.

Receipt and identification of the cultures and sub culturing of the standard cultures and in-house isolates.

Carry out Validations, Calibrations/ Verifications, and Equipment qualification, when required

Bioburden of Primary packing material and trend preparation.

Follow the written testing procedure for routine and scheduled analysis of Biological indicator. Biological Indicator log updation and stock maintenance.

Maintain, control and usage of QC sampling tools and containers

Preparation of trend, summary, layout, justification and test data sheet of environment monitoring.

Update of SOP’s, WI’s, technical layout and other required documentation as assigned by Microbiology Supervisor.

Any other assignment allocated by the Microbiology Quality Control Supervisor and Quality Control Manager/ Head of Quality.

EQUIPMENT MANAGEMENT

Maintenance of equipment as per relevant procedures.

Malicious use to be avoided.

COMPLIANCE 

Immediate reporting OOS/OOAC/OOAL/OOT, deviation or any other aberration to Microbiology Supervisor and subsequent involvement in relevant investigations.

Compliance to WI and SOP.

Repeat Analysis to be kept to minimum

DATA MANAGEMENT

Complete all the relevant entries of test performed and compilation of relevant data before submission for review.

Sample log updation after starting and completion of analysis and schedule updation.

Ensure that all sampling schedules, logbooks, analytical data sheets and other documentation is completed timeously upon sampling and entering of data.

HOUSEKEEPING AND SAFETY 

Follow safety precautions while working in area and to ensure appropriate PPE is worn at all times.

Timeous disposal of waste and tested material as per relevant procedure

Sterilzation of glassware and accessories used in the sampling and testing procedures.

Decontamination of the media, checking of record.

Ensure cleaning of areas and equipment as per approved procedure. Maintain availability of disinfectants/ cleaning agents within lab.

Dimensions

Routine testing of Water, Environmental Monitoring, Personnel, Compressed Air.

Testing of Raw Materials, Intermediates and Finished Products.

Producing and Verifying Microbiological Media

Standard Lead Time > 90%

SOP Training > 90 % per month.

Safety Incidents:  0 per month

Quality Score card > 85 % per month

Critical Findings: Nil 

Skills & Knowledge

Educational qualifications:

Diploma / BSc / BTech Degree in Microbiology / Biotechnology / Applied Science

Relevant experience:

1 to 2 years in a Micro laboratory environment