Job Responsibility of Microbiologist

•  Maintenance of Mother Culture, Periodic Sub Culturing and Destruction of Obsolete cultures and maintain records of the same. Procuring, and storage of dehydrated media

• Preparation, maintenance and decontamination of used media. Water sampling and analysis.  

• Environmental monitoring by settle plate, air sampling, surface sampling.

• Personnel monitoring by contact plate method and finger dab test method.

• To perform the Microbiological Assay’s as per the requirement

• Microbial limit test for raw materials, In-process and finished products.

• Validation of disinfectants.

• Identification of environmental isolates and corrective action.    

• To monitor the microbial load of compressed air.    

• Participation in aseptic media fill validation.

• Bio-load determination on sanitized equipment and machines.

• Preparation of Trend analysis chart for water and environmental monitoring.
  Microbiology Compliance Management: (but not limited to) 

• Review of procedures, records and activities

• Review of procedures and protocols for compliance to regulatory / pharmacopeia requirements and industry standards.

• Review of activities and practices for compliance to established procedures. The activities to be reviewed includes but not limited to:

• Microbiological Analysis

• Sampling activities

• Observation of results

• Media preparation and testing

• Equipment & Instrument Operations 

• Culture and Inoculum Management

• If any gaps / anomalies or opportunities for improvement are identified in procedures, activities or practices appropriate corrective and preventive actions shall be initiated. 

• Prepare of records, reports, logbooks and analytical/ raw data sheets for completeness and correctness of data and traceable information.  The documents to be reviewed includes but limited to: 

• Equipment usage logs and calibration records 

• Media Preparation, testing and usage records 

• Sterilization records

• Analytical / Raw Data sheets of Microbiological tests 

• Culture maintenance and inoculum preparation & usage records

• Media, Reagents and Indicator suitability testing and stock records

• Environmental, Water and Utility Monitoring schedules, reports and trend

• Method and Miscellaneous Validation reports

• Microbiological deviations and OOS investigation reports

• Prepare documents shall be performed based on the frequency of activities performed and criticality of activities. 

• During review of documents wherever possible, the data reported shall be verified physically against the   test results / observations and physical stocks.

• All reviewed documents shall be counter signed by the compliance representative.

• If any anomalies are observed during the review, the same shall be escalated and addressed through appropriate Quality Management System with appropriate investigation and CAPA. 

• Investigation of Microbiology Deviations and OOS

• Participate in investigation of critical Microbiology deviations and OOS for identification of root causes and implementation of appropriate CAPA to prevent reoccurrence of similar incidents.

• Evaluate effectiveness of CAPAs implemented. Internal, and External Audits

• Involve in preparation for audits and participation in audits.

• Implementation of necessary CAPA for audit observations.

• Evaluation of site procedures and practices for compliance to audit observations from other sites and initiate appropriate CAPA 

• Sharing of audit observations, investigation and review findings and CAPAs across all sites for implementation as appropriate.

• Evaluation of other site’s observations, investigation and review findings and CAPAs for compliance and implementation appropriate CAPA.

• Revision and effective implementation of common procedures across all laboratories.

• Implementation of best practices across all laboratories.
                 Regulatory Compliance

• Perform periodic review of regulatory guidelines and regulatory citations from GMP trends, Gold Sheets and Warning letters.

• Follows SOPs, current good manufacturing practices, company policies, health, safety and environment procedures, human resources policies, etc. and stays updated as and when revised.

Place of Work: Addis Abeba/Killinto Industrial Park

Salary: Negotiable

Qualification:

1. Bachelor of Science with Microbiology/ Biotechnology with 2 to 3 years of experience in pharmaceuticals manufacturing industry.

2. In and out knowledge about operation of the analytical instruments in a Pharma company.

3. Knowledge of documentation

4. Fluent in English reading, writing, speaking, interpreting.

5. Able to work in any shift as per company requirements.

6. Desirable: Sense of urgency, work efficiently in fast paced environment with less supervision, under pressure. Flexible to adapt newer responsibilities, positive mindset.

Working in the Manufacturing sector is advantageous.

How To Apply

Applicant should send their CV and educational credentials through the following email. 
yogeshkamble@africurepharma.com / yonas.a@africurepharma.com