Sudheer Kumar Kasi

About Sudheer Kumar Kasi

Expertise in Solving the issues with Serialization process in Antares Tracking System for the client LEO PHARMA2.Fully involved in Validations, QUALIFICATIONS (FAT, SAT, IQ & OQ)of PACKAGING MACHINES like labeller-blister-cartonator-auto check weigher-over wrapper-case packer-auto check weigher of fully integrated line, Model: CAM packaging technologies.3. Fully involved in QUALIFICATIONS (FAT, SAT, IQ & OQ) of SERIALIZATION PROCESS for Cartons-Bundles-Cases-Pallets by ANTARES VISION SYSTEM 4. JEKSON USA Vision system Operation and troubleshooting.5. Preparation of Standard Operating Procedures (SOP).6. To monitor the in-process checks.7. Supervision of Production Inspection and Packing areas. Preparation of validation protocols.9. To maintain & review the Documents (BMR & BPR) of production.10. To maintain area/equipment cleaning and sanitization activities as per respective SOP’s.11. Vast knowledge on Operation, Cleaning, Changeover of machine, including their trouble shooting’s etc. as per SOP’s.12. To maintain cleaned rooms as per cGMP.13. Involved in SAT, IQ, OQ of INSLIN PEN ASSEMBLY MACHINE (MAKE: MICKRON) for shorter period.14. Involved in SAT of INSULIN PEN LABELLING MACHINE (MAKE:MARCHESINI)15. Involved in SAT, IQ of INSULIN PEN Primary, Secondary & Tertiary Packing Machine (MAKE: BILCARE).16. In-process for Online and Offline inspection of ampoules(clear & amber glass), vials (clear and suspension) and cartridges (clear and suspension)17. Printers of various varieties (Make: Markem Imaje Printer, wolke printer).

Experience

1. Lead Consultant

   HCLTech

   Feb 2021 — Present · Hyderabad, IN

   Serialization L3 Support for issues regarding line management system.Configurational changes in L3 systemImplementation of L3 system right from building the servers to configure the application in the serverSKU issuesSerial Number range definitionsValidations and Qualification in ALM Tool like IQ, OQ, PQ, RQ and UAT testsDocument handling and change management by Veeva Vault applicationPeriodic Review Reporting (PRR) and User access reviewReview of documents like URS, DS, FS, HDS, SDSDeveloped and obtained approval for URS Traceability Matrix to identify all tests case executions and detect any GAPSAbundant experience in generating and reviewing CSV deliverables according to 21 CFR Part 11 and GxP FDA regulations

Education

• Vignan College of Pharmacy

  Bachelor of Pharmacy (B.Pharm.), Pharmaceutical Sciences

  2010 — 2012

• Andhra University

  Master's degree, Pharmaceutical Sciences

  2012 — 2014

• Venkateshwara Open University

  Master of Business Administration - MBA, Health/Health Care Administration/Management

  2016 — 2018

• State Board of Technical Education and Training

  Diploma in pharmacy, Pharmacy

  2007 — 2009