Swapnil Ramesh Baviskar

To perform sterility in the isolator.

To perform method suitability of sterility test and MLT.

To perform Microbial identification using vitek 2 compact.

To perform daily water sampling and analysis using millflex oasis filtration system.

To perform BET of WFI samples and PSG samples.

To plan and coordinate with the manufacturing unit for the EM activity.

To develop and prepare EMPQ protocol and report.

To perform the Particulate matter testing of the FP using LBPC.

• Independent Planning and Allocation of work to subordinates for execution of work in Microbiology laboratory.
• Review of All Microbiological Data and Reports.
• Review of Standard operating procedures, protocols for validations, requalification’s activity.
• Handling of Laboratory investigations, OOS, OOT Investigations and deviations.
• Review of calibration activity for equipments and instruments.
• Initiation of Change controls Related to SOP / Protocols.
• Overall management of lab with respect to GLP/ GDP, Documentations practices.

• MLT Method validation of Raw materials and finished products.
• Performing Microbiological Limit Test for non sterile products.
• Identification of Microorganisms by using Vitek 2 compact identification system.
• Cryovials preparation, revival and maintenance of microbial cultures.
• Microbial analysis of potable & purified water.
• Sterility testing by open and closed methods.
• Biological indicator evaluation.
• Monitoring and review of Incubators data logging through software.
• Review of Media Preparation, Growth Promotion Test, Maintenance of Media stock, Chemical Stock.
• Preparation of Monthly, Yearly Trends and Summary Report for Environment Monitoring, Water analysis results.
• Validations and qualification of Equipment’s like Autoclave, Incubators, Dry heat sterilizer.
• Review of daily activities, reports and checked Good Laboratory Practices.
• Handling of SOP related Change Controls through Track wise system.
• Handling and coordinating in Deviations through Track wise system.
• Handling of Microbiological incidences.
• Handling of Investigations of OOS / OOT results in microbiological testing.
• Training Coordinator in Microbiology Laboratory through SABA Software.

• Preparation of media and performed Growth promotion test, inhibitory test, preincubation check test.
• Monitoring, and cleaning of Microbiology Laboratory.
• Preparation and Disposal of microbial culture media.
• Microbiological Monitoring of Environment in production area along with Microbiology Laboratory.
• Identification and Maintenance of Standard cultures and In-house isolates.
• Microbial Limit Test of raw materials and finished products as per harmonized method.
• Bioburden testing of in process and packing materials.
• HVAC Qualification.
• Autoclave validation.
• Microbial analysis of potable and purified water.
• Trend analysis of water and environmental count data.

• Environmental monitoring by air sampling, settle plate techniques.
• Media Preparation and GPT.
• Water Analysis for Purified and potable.
• Daily Cleaning and Disinfectant Preparation.

• Environmental monitoring by air sampling, settle plate techniques, surface monitoring and finger dab monitoring in sterile manufacturing area.
• Participate in Media fill operations.
• HVAC qualification in production area.