Kishore Goud

Assistant Manager @Shantha Biologics Private Limited

Medchal, IN

Having 9+ years of experience in both Project ENG and CSV Quality Engineer.Hands-on experience in AGILE Project Management using JIRA, and Kanban tools.Experienced in converting the Business Requirements into Technical Specifications.Prepare and review capex budgets for newly procured equipment.Preparation, review, and Execution of Qualification protocols (URS/DQ/FAT/IQ/OQ/PQ).Management for end-to-end project Delivery, i.e. Initiating, Planning, Executing, Monitoring & Controlling and Handover and Overall leadership for System project execution and documentation.Handling design verification, Installation Qualification (IQ), Operational Qualification (OQ).Project Management and importance of time lines (On Time, In Budgeted Cost with Quality).Conduct Internal checks and self-inspection and CAPA implementation.Overall responsibility to lead computerized system validation (CSV) and any Automation upgrade work with the help of OEM and Site Team.System breakdown analysis - FMEA, RCA, CAPA and supporting for MTTR & MTBF (OEE improvement ). Overall responsibility to lead computerized system validation with the help of OEM, including protocol preparation, review and execution as per cGMP, EU annex 11 & 21CFR Part11.Execute FAT, SAT and validation procedures of process machinery and qualification with SCADA System.Have hands-on Computer System Validation (CSV) activities like Periodic review categorization, Audit trail review, Privileges matrix, User Management, and manual/auto backups.SOP Preparations using DMS application Software and Handling the Deviations & Change controls using QMS application software.Managing the technicians, and the operators and giving guidance in technical aspects.Performing internal Audits for CFT departments and compiling and implementing audit observations.Actively involved in the Successful completion of audits of USFDA, EUGMP and WHO.

Progressive Engineering College

Bachelor’s Degree

JNTUH College of Engineering Hyderabad

Bachelor of Technology - BTech