Sathis Kumar Email & Phone Number

Bengaluru, Karnataka, India

1.Ensuring the GMP requirements while performing qualification and validations.2.Ensuring QA validations oversight,assigning risk/impact on validated state during any facility,clean utilities, equipment related deviations,change controls and CAPAs.3.Review and approval of facility related drawings/layout (For ex, AHU zoning, Area classification, Equipment layouts.)4.Review of preventive management & calibration instrument related procedure, planner verification.5.Ensure QA validation oversight during periodic HVAC, LAFs, BSCs related re-validation activities.6.Handling of TrackWise for follow-up and closure of all QMS elements for QA validation department.

Bengaluru, Karnataka, India

To allot & update the document number for validation, revalidation, campaign change protocols & reports, URS VMP, CVMP etc.2. To allot & update the equipment identification number for new and relocated equipment to be installed in the various blocks.3.Document control of SOPS, protocols and other related documents pertaining to validation section.4.Preparation of Standard Operating Procedures, Validation and Revalidation Protocol pertaining to Validation, Qualification & Risk Assessment Activities.5.Monitoring of Validation and Qualification activitiesrelated to the equipment, system and facilities.6.Preparation and review of Validation and Revalidation Reports pertaining to Validation / Qualification activities the facilities.7.Preparation of Revalidation Planner and coordinate the Revalidation of equipment / faility/processes.8. To allot tracking number, update and track the activities pertaining to facility & equipment shutdown number.9. To review the trend analysis report of environment monitoring and critical system and ensures compliance o agreed EMP schedule.10. To review the temperature record of equipment deep freezer, ultra-low temperature freezer and cold room used for the critical activities.11. To ensure the review and archival of Calibration Certificates pertaining to In-house and External Calibration activities.

Bengaluru, Karnataka, India

As a Validation Engineer, Responsible for the testing and Validation of Pharmaceutical Clean Rooms, LAF, HVAC Systems and Bio-Safety Cabinets.1. Hands-on Experience in performing Air Volume & ACPH test, HEPA Filter Integrity testing, Temperature and Differential Pressure measurement, Non-Viable particle count test, recovery test and Air Flow pattern test.2.Preparation and Review of Validation test sheets, reports, Calibration certificates and raw data.3. Providing Training to the clients as and when required on the validation procedures.. 4.preparation and review HVAC planner andprotocol for qualifications activities... 5.segregation and verify the test reports and raw data copy...6. preparation and review temperature mapping planner and protocols..7.commands rectification of the report and co-ordinate with QA department... 8.client visiting and co-ordinate with plants area and clean room facility...

Bengaluru, Karnataka, India

As a Validation Engineer, Responsible for the testing and Validation of Pharmaceutical Clean Rooms, LAF, HVAC Systems and Bio-Safety Cabinets.1. Hands-on Experience in performing Air Volume & ACPH test, HEPA Filter Integrity testing, Temperature and Differential Pressure measurement, Non-Viable particle count test, recovery test and Air Flow pattern test.2.Preparation and Review of Validation test sheets, reports, Calibration certificates and raw data.3. Providing Training to the clients as and when required on the validation procedures. 4. Providing timely validation support to the client's and closing the issues with adequate measures.5.. Troubleshooting and servicing of equipment's and instruments used for validation activity.

Bengaluru, Karnataka, India

Started my career as a Graduate Engineer Trainee in B1-Block- Mammalian Cell Culture Facility. Involved and gained knowledge on the following activities.1.Coordinated for the modification activity and Validation of Clean rooms.2.Gained knowledge on the Preventive. Maintenance of Process Equipment's like Bioreactor, Chromatography columns / systems and Process Vessels.3.Learned the basics of Good Manufacturing Practices, Clean room behavior and Good Documentation Practices.