Senthil Kumar Email & Phone Number

India

Indore, Madhya Pradesh, India

Injectables

Bangalore

Insulin -QA

AREAS OF EXPERTISE Aseptic processing Quality Management system elements Process Validation of injectable formulations Aseptic Process Simulation (Media fills) Annual Product Quality Reviews Quality Risk Management Document control Batch record review and batch releases Trainings Handling of audits and inspections Vendor audits and management

India

Conducting Internal Quality audits, Vendor audits, Contract Manufacturing site Audits and Contract Laboratory Audits • Coordinating the external Regulatory & Customer audits • Handling of Change controls and Non‐Compliance reports (Planned & Un‐planned Deviations, Out of Trend Reports & Out of Specification Reports) • Review & approval of validation protocols & reports pertaining to Purified Water System, HVAC, Equipments, Manufacturing Process,• Liaison with state FDA to update the approval of license •

Tarapur,Mumbai

Monitoring of HVAC and Water System Validation processes with respective to the approved protocols and compiling the reports • Review of Records of Analysis to ensure the quality of raw materials, water and finished product. • Review of Proposed & Revised Specifications and Standard Test Procedures based on official Pharmacopoeias and data generated during validation.

Pondicherry,India

Environmental monitoring of clean rooms in manufacturing facility • Growth promotion testing of microbiological media, Routine testing for all batches of media used within the manufacturing facility as per USP • Maintenance of pure cultures as per USP & Identification of pathogens in Raw material, finished products as per USP • Handle the Microbiological analysis of purified water and monitor the purified water system performance. • Responsible for the operation and maintenance of all laboratory equipment and instruments