Arun Sasikumar

I am responsible for leading SCAN RDI and D-count/ Bactiflow/VIDAS/TEMPO/Vitek MS/Vitek 2 Compact Project in terms of implementation , Validation and FDA filing at various pharma sites and Food Beverage sites , attending customer queries with respect to techniques and regulations and giving training to customer teams and leading the application team for successful on-time completion of validation implementation of systems and completion of troubleshooting. I am also responsible for conducting scientific seminars , demonstrations , and supporting sales team for increasing reagent sales .

I lead an application team consists of 6 field application specialists and 4 project trainees dedicated for validation , troubleshooting, demonstrations, and scientific activities.

• Total Experience – 10.2 years.
• Roles and Responsibilities: Manager Industry application Support bioMérieux I am responsible for leading SCAN RDI and D-count/ Bactiflow/VIDAS/TEMPO/Vitek MS/Vitek 2 Compact Project in terms of implementation , Validation and FDA filing at various pharma sites and Food Beverage sites , attending customer queries with respect to techniques and regulations and giving training to customer teams and leading the application team for successful on-time completion of validation implementation of systems and completion of troubleshooting.
• I am also responsible for conducting scientific seminars , demonstrations , and supporting sales team for increasing reagent sales.
• I lead an application team consists of 6 field application specialists and 4 project trainees dedicated for validation , troubleshooting, demonstrations, and scientific activities.
• Achievements:.
• I lead the team and played a key role in successful implementation and FDA, EU , Indian FDA approval of rapid.
• Microbial method for sterility in Aurobindo Unit 16 , Astral Pharma, Cipla , Gujrat Food and Drug Laboratory.
• Closely worked with Regulatory and CQA SME’s for the implementation.
• Played a major role in increasing the sales of SCAN RDI.
• I played a vital role in QC microbiology for Bioassay , culture maintenance, routine PET , MLT testing and method validations and development for R&D samples.
• Achievements: Successfully completed USFDA audit and many other regulatory and customer audits GSK, J&J, Pfizer, Cipla.

• In my role as officer quality control in Microlabs, I was responsible for area monitoring, media preparation, method validations, mlt testing, culture maintenance, PET, DET, sampling of raw materials and bioburden testing of the same (Need to add details).
• Faced many regulatory and customer audits.