RAMABABU DIDLA

• Led the Process Engineering department with 6 filling lines, coordinating activities and providing support to cross-functional teams.
• Managed QMS elements, including deviations, change controls, and CAPA, ensuring timely compliance with regulatory requirements.
• Review, approval and execution support for all the Validation & CSV documents for the equipments as per cGMP and 21 CFR part 11 compliance requirements.
• Oversaw engineering documentation (URS, DQ, IQ, OQ, PQ, SOPs, calibrations, history cards, preventive maintenance plans) in engineering and maintenance department per cGMP standards.
• Develop, Support and review technical documentation URS, DQ, FAT, SAT, IQ and OQ, lead to participate and execute commissioning and qualification process.
• Responsible for new Project design, erection, Execution, commissioning & Qualification of all Engineering Equipments.
• Successfully completed the Installation & Qualification activities of Ampoule Line with Washing Machine, Tunnel, Filling Machine, Vessels and other equipment.
• Led projects aimed at enhancing productivity, improving quality, reducing downtime, and increasing safety and energy efficiency.
• Maintenance and Troubleshooting of Process equipments in the plant like Vial Filling Machine (Tofflon), Ampoule Filling Machine (Tofflon), PFS Filling Machine (Grouningr), Cartridge Filling Machine (B+S), Washing Machine, Tunnel, Isolators, Autoclaves, Terminal Sterilizers, Vessels and all other process equipments.
• To review documents pertaining to preventive maintenance/breakdown, Calibration, Validation, qualification of machine/equipment user system/instruments as per SOP & schedule.
• To assist in preparation of the capital budget associated with the smooth functionality of the maintenance and assigned relevant projects.
• Ensure availability of spares for all the equipment and preparation of inventory, monitored and tracked to comply with all statutory requirements.
• Prepare and participate in internal and external audits along with all-time readiness.

Projects Handled:

• Successfully completed the Installation & Qualification activities of Ampoule Line with Washing Machine, Tunnel, Filling Machine, Vessels and other equipments.

• Responsible for leading the Instrumentation & Calibration department with 1 Filling Line, overseeing all activities and acting as the single point of contact for coordination and support to cross-functional teams.
• Responsible for new Project design, erection, Execution, commissioning & Qualification of all Engineering Equipments.
• Maintenance and Troubleshooting of Process equipment in the plant like Dual Chamber Vial Filling Machine (M&O Perry), Active Freeze Dryer (Hosokawa), Washing (Marchesini), Tunnel (Marchesini), Isolators (Comecer), Autoclaves (Fedgari), WFI Tank and Mixing Tank equipments and NVPC Systems and etc.
• Maintenance and Troubleshooting of Utility equipment in the plant like Building Management System, Utility Monitoring System, Pure Water Generation and Distribution, Water For injection Generation and Distribution, Pure Steam Generation, Boilers, Chillers and Compressors and etc.
• Maintenance and Troubleshooting of security systems like Closed Circuit Television systems (CCTV), Door Interlocking systems, Access control system, Fire Alarm System, Public Addressing Systems etc.
• Maintenance and troubleshooting of Microbiology and Quality Control Equipment, Stability Chambers and etc.
• Ensuring the timely completion for Calibration of instruments, Preventive maintenance of equipment and general verifications as per approved schedule/planner.
• Review and execution of Equipment qualifications, Validation, CSV (Computer system validation), URS, FAT, DQ, IQ, OQ, PQ. GAMP (GxP) assessments, 21CFR part 11 assessments.
• Responsible for handling of all the QMS elements like Deviations, Change controls, CAPA, S- CAPA, Exceptions and timely completion.
• Responsible for the preparation, controlling and monitoring of CAPEX and OPEX.
• Ensure availability of spares related to instrumentation and Automation system and preparation of inventory, monitored and tracked to comply all statutory requirements.

Projects Handled:

• Successfully completed the Installation & Qualification activities of Dual Chamber Vial Filling Line for all process equipment Like Washing Machine, Tunnel, Dual Chamber Vial Filling Machine (M&O Perry), Active Freeze Dryer, Isolator, Vessels, Autoclave and Others.

• Responsible for leading the Instrumentation & Calibration department, overseeing all activities and acting as the single point of contact for coordination and support to cross-functional teams.
• Responsible for new Project design, erection, Execution, commissioning & Qualification of all Engineering Equipments.
• Maintenance and Troubleshooting of Vial/Ampoule Filling machines, Autoclaves, Super-Heated Water Spray Sterilizers, packing machines, CIP and SIP Equipment and NVPC Systems.
• Maintenance and Troubleshooting of utility equipments in the plant like BMS, Pure Water Generation and Distribution, Water For injection Generation and Distribution, Pure Steam Generation, Boilers, Chillers and Compressors.
• Maintenance and Troubleshooting of security systems Closed Circuit Television systems (CCTV), Fire Alarm System, Public Addressing Systems etc.
• Maintenance and trouble shooting of Microbiology and Quality Control Equipments, Stability Cambers and etc.
• Responsible for PLC programming & SCADA modifications related to Process Equipments, BMS, EMS and UMS.
• Ensuring the timely completion for Calibration of instruments, Preventive maintenance of equipments and general verifications as per approved schedule/planner.
• Review and execution of Equipment qualifications, Validation, CSV (Computer system validation), IQ & OQ.
• Responsible for handling of all the QMS elements like Deviations, Change controls, CAPA, S- CAPA, Exceptions and timely completion.
• Ensure instrumentation and Automation Inventory prepared, monitored and tracked for availability.
• Responsible for the preparation, controlling and monitoring of OPEX.

Projects Handled:

• Successfully completed the Installation and Qualifications for total 6 Filling Lines with Integrated Building Management System includes BMS, EMS, CCTV, Access Control, Door Interlock, Fire Alarm, and Public Addressable System and Qualifications.
• Successfully Completed the Installation and Qualifications for Process Equipment of Autoclaves, Terminal Sterilizer, NVPC, VPC and Others.

• Planning, execution and commissioning of projects at site.
• Break down maintenance of instruments (Indicators, transmitters, controllers, sensors and drives etc) and Equipments (Automation systems, Autoclaves, Freezers and others)
• Calibration of all field instruments like gauges, transmitters, Indicators, Sensors, weighing balance etc.
• Routine and Preventive maintenance of instruments, water treatment plants, microbiology & QC related equipments and automation systems etc.
• Total Instrumentation related document control i.e. Instruments list & Instrument Planner preparation, periodic calibration certificates preparation, change controls, instrument breakdown records and any deviations.
• Preparation of SOPs, IOPs and qualification related documents compliance with cGMP norms.
• Periodic validations and temperature mappings for VTDs, cold rooms, clean rooms and QC & microbiology related equipments like autoclaves, deep freezers and ovens etc.
• Selection of appropriate vendor, negotiations and follow-ups with vendor.

Projects Handled:

• Successfully completed the new Production block with all the instrumentation support and automation support by Installing Reactor Utility Automation, VTD’s Integration, Installation & Commissioning of Water System and Other equipment controlling.

• Lead multiple projects for different applications concurrently and responsible for timely development, implementation and functioning of the automation systems.
• Planning, execution and commissioning works at site.
• Discussing with the customer about the requirement of the project and as per that designing of the project and execution.
• Preparation of Qualification Documents and execution.

Projects Handled:

• Installation and commissioning of the Centralized SCADA for Water Treatment Plant in Aurobindo Pharma Ltd., Unit-XII, Bachupally, Hyderabad, A.P on Allen Bradley Micrologix System with documentation.
• Installation and commissioning of BMS in Aurobindo Pharma Ltd., Unit-XII & Unit-V, Hyderabad on Schneider Electric TAC Xenta system with documentation.
• Installation and commissioning of BMS, CCTV in Surya Pharma Pvt Ltd., Samba, Jammu on Schneider Electric TAC Xenta system with documentation.
• Installation and commissioning of BMS in AuroNext Pharma Pvt. Ltd., Bhiwadi, Rajasthan on Schneider Electric TAC Xenta system with documentation.
• Installation and commissioning of Fire Alarm System in Aurobindo Pharma Ltd., Unit-12, Unit – 1, Head Office, NCC Power Plant with EST Fire Alarm System.
• Installation and commissioning of Fire Alarm System in Dr. Reddys Laboratiries Ltd., CTO - IV with Honeywell Fire Alarm System.
• PLC Validation in Granules India Limited, Gagillapur, Hyderabad on different PLC’s Allen Bradley, Siemens, Omron and Mitsubishi with documentation.