Rahul Jadhav

• Ensuring Compliance of entire group per Eugia quality
• Standards and regulatory requirement
• Coordination with Global quality team for identifying GAPS
• In Procedures, Process and evaluation of them
• Participating in batch planning meetings and ensuring
• Timely testing and release of reports to batch release
• Team.
• Guiding team leads for fixing issues and providing
• Solution for completion of impacted process
• Successfully achieved 5S certification of Microbiology lab.
• Process simplification projects: 1.Successfully removed
• Incubator/Autoclave printout process and implemented
• Online review mechanism. 2. Prepared standalone recording
• Worksheets for BET/Sterility/Bioburden forms and removed
• Recording worksheets issued from QA.
• Reduced Environmental monitoring samples of
• Microbiology lab through prospective risk analysis and
• Developing rationale for sampling locations
• Established Incident rate of environmental monitoring
• Samples of classified rooms.
• Responsible for performing Site manufacturing Investigations and initiation of CAPA as per requirements Performing Quality Audits at manufacturing locations Ensuring compliance of microbiology lab. Preparation of new Standard operating procedure and Validation protocols Facing regulatory audits and internal audits
• Training all Microbiology team members for Aseptic Techniques, gowning procedures as per CGMP
• Supervised day-to-day operations to meet performance, quality and service expectations
• Improved customer satisfaction by addressing and resolving complaints promptly
• Developed strong working relationships with staff, fostering positive work environment
• Developed strong working relationships with staff, fostering positive work environment

Senior executive QA

Review of Microbiological investigations related to Environmental monitoring.

Monitoring of sterile injectable manufacturing process.

Participation of media fill activity.

Review of batch Manufaturing records.

Testing of RM, PM, Stability & Finished Product MLT, sterility and BET.

Handling of Investigations related to Sterility Failure, MLT , Water and Environmental excursions.

MLT Validation.

Sterility validation.

Environment monitoring of Aseptic area, Non sterile area.

Monitoring Quality of Water(Purified water, potable water,

Water for Injection, Pure steam)

Bioburden and sterility checking of Compressed air and Nitrogen gas. (by Pinocchio compressed air sampler and T-

shaped glass assembly)

Bioload Checking in Cleaning Validation by cotton swab

technique.

Media Preparation, Preincubation check and Growth

promotion test.

Environment monitoring of Aseptic area, Non sterile area.

Preservative Efficacy Test.

Water Validation.

TVC of Biological Indicator.

Microbial cells Culture Maintenance.

Non Routine Studies Performed:

Determination of Exposure period for settle plate ISO 8 area

and D Grade.

Determination of viable count of test organism up to its

validity period.

Effect of sterilization time on properties of media.

Validation of extended storage period of Fourth passage of cultures

Hold time of swabs after sampling.

Storage period of culture dilutions.

Storage period of prepared media and media plates.

Storage period of sterilized sampling accessories.

Validation of Gowns and dustors for storage and usage period

in MICROBIOLOGY Laboratory.

Evaluation of stopping of HVAC system after operations and during weekly and holidays for Grade C.

Sampling and testing of Water sampler.

Testing of RM and Finished Product MLT. Media Preparation and Growth promotion test. Environmental monitoring of production area.