Manager 1 - Microbiology

Education : M. Sc. (Microbiology)

Experience : 12 + Years

1. Arpit Thakkar reports to her superior C. Suresh Kumar

1. Arpit Thakkar is responsible for:

1. Authorize to sign ( as a doer & reviewer ):

1. Parenteral GMP documents
2. Aseptic area monitoring data

1. Risk Assessment

1. To participate in the aseptic process risk assessment.
2. To participate in evaluating the sampling locations for environmental monitoring based on risk assessment and critical interventions.
3. To evaluate and perform risk assessment of air flow and air classification based on aseptic process involved like filling, filtration, lyophilization and capping.

1. Qualification and Validation

1. To review the qualification protocol and reference related to area qualification.
2. To review smoke study protocol and executed videos.

1. Media Fill

1. To participate in media fill process. Evaluate the protocol for interventions to be perform and review of media fill related documentation.
2. To monitor aseptic practices during routine production and media fill runs to evaluate and to suggest improvement in practices if required.

1. Monitoring

1. Oversight of the aseptic operations, environmental monitoring activity - for viable particle count (VPC) and Non-Viable particle count (NVPC).
2. Sampling, testing, evaluation and interpretation of environmental monitoring VPC, NVPC, PEP and utility monitoring (nitrogen gas, compressed air, CO2 gas) results.
3. To review trend for viable and non-viable monitoring data and suggest action if any.
4. To review trend of microbiological monitoring of personnel of aseptic area.
5. To train the personnel entering the aseptic area, qualify, disqualify the personnel for aseptic area entry.

1. Investigation

1. To review the incident related to aseptic practices.
2. Participate in the microbiological related incidents, investigation and other microbial impact assessment wherever and whenever required.

1. Communication between QA and Microbiologist

1. To review the observation given by QA related to aseptic area and sterility assurance and do the necessary impact assessment.
2. To inform QA and production for any environmental monitoring incident.

1. Training

1. To impart the training of continual improvement on aseptic process and sterility assurance as per global CAPA provided by Corporate Quality. (e. g. PDA, USFDA, Warning letters related to aseptic practices and sterility assurance, EU Guidelines and others).

1. Documentation

1. Documentation of the activities according to defined SOP.
2. SOP preparation and it s timely revision or as and when required.
3. Preparation and execution of study protocol.

1. Any other responsibilities assigned from time to time orally or in writing by Department Head.