Jagannadh Gopisetti
Rajahmundry
Summary
I am Mr. Jagannadh Gopisetti, a seasoned professional with a robust 16 years plus track record in the manufacturing & pharmaceutical industry, specifically within the realms of Oral Solid Dosage (OSD), Formulations, and Biologics. My expertise encompasses Process Control Instrumentation and Automation systems. With a solid grasp of regulatory compliance, I am well-versed in 21 CFR Part11 and Computer System Validation (CSV) of process equipment, aligning with GAMP5 guidelines. My commitment to quality is further evidenced by my knowledge of Quality Management Systems (QMS), adherence to Good Engineering Practices (GEP), and the implementation of industry Standards (GxP), all of which are integral to maintaining excellence in my field.
In Addition, currently pursuing Project Management Professional (PMP) Certification from Project Management Institute (PMI).
Overview
17
17
years of professional experience
1
1
Certification
Work History
Associate Manager (Instrumentation/Automation/CSV)
Biocon Biologics Limited
09.2022 - Current
- Actively contributing to the IT applications, project initiatives that includes Validation activities as per GAMP Life Cycle and SDLC/Governance
- As a Project Lead for L2 Integration of all process equipments in Fill Finish facility and Packaging line equipments
- Involved in Business process transformation programs like SAP PM Module, LIMS, TrackWise, eVLMS (ValGenesis) and its Documentation
- Troubleshooting of IT/OT application related issues, Software, Hardware, Servers and Networking
- Performing Gap Assessments and providing Remediation procedures to ensure the equipment/system in validated stage throughout the Life cycle
- Preparation/Execution of Test Protocols which includes URS,SDS,HDS,FS, FAT, SAT, IQ, OQ of the equipments
- Execution of Computer System Validation (CSV) of all process equipments in the facility to comply the USFDA 21 CFR Part11 & EU Annex 11 standards
- Good Understanding and Knowledge of Computerized Systems Validation concepts such as GAMP5 and Risk Based approach to compliant GxP systems
- Good Understanding of Data Integrity (DI), Quality Management System (QMS) elements such as Deviation, RCA (Investigation Reports), CAPA and Change Controls
- Handling of Field Instrumentation & its Calibrations Compliance as per ISO 17025 testing & calibration procedure guidelines
- Operations/Troubleshooting of BMS and EMS by Siemens Desigo CC & Honeywell EBI R600
- Handling of Breakdown Maintenance and its Troubleshooting of DCS, PLC, HMI, IPC and SCADA based Control systems and making monthly MTTR and MTBF reports
Senior Executive (Instrumentation & Automation)
National Pharmaceutical Industries Co. (SAOC)
08.2017 - 06.2022
- As a Lead Engineer (Instrumentation & Automation) Projects & Maintenance of OSD Facility
- Actively involved of all Process Equipments Qualification and its Computer System Validations to comply the 21CFR Part 11 (Electronic Records/Electronic Signatures)
- Hands on Experience in Process Equipment's Troubleshooting (Tablet Compression Machines: Bosch/Syntegon TPR 500, Sejong)
- Blister Packaging Machines: CAM, Hoonga), Bosch XL150 Coating Machines, Bausch Stroebel Labeling Machines with Track & Trace Serialization and Visual Inspection System of Jekson Vision USA
- Handling of Jekson Blister Inspection System (BIS) and Barcode Pharmacode (BPO) Pharmaceutical Packaging Control System.
Senior Team Member in Engineering Services
Dr.Reddy's Laboratories Limited FTO SEZ Unit
08.2014 - 08.2017
- Plant Lead Instrumentation & Automation Engineering Projects and Maintenance
- Involved in Process Equipment Qualifications & its PLC Validations
- Handling of GxP Assessments & CSV of all Process Equipments
- Active Member in Process Safety Management (PSM) & Pre-Startup Safety Review (PSSR)
- Handling of CCTV Surveillance System, Access Control System (ACS), Fire Alarm System (FAS) and Public Addressing System (PAS) in the facility provided by Honeywell OEM as a Integrated BMS (IBMS)
- Good Exposure to Data Integrity (DI) and ALCOA+ Principles.
Engineer in Projects and Maintenance
DRT Anthea Aroma Chemicals Private Limited
03.2012 - 08.2014
- Instrumentation Lead in Process Maintenance Department
- Involved in Plant Equipment Upgradation (Automation) Projects to ensure compliance with latest Quality standards
- Experience in FMECA, HAZOP study, ON site & OFF site Emergency Plan Implementations with EHS team.
Instrumentation Engineer
Siemens Ltd, Kalwa, Thane
06.2010 - 02.2012
- As a Instrumentation Engineer involved in Plant Maintenance (Preventive/Breakdown/Predictive)
- Programming & Troubleshooting of SIEMENS G-120 & S-120 AC VFD's
- Handling SIEMENS S7-300 & S7-400 PLC's
- Site Safety Coordinator, Preparation of Job Safety Analysis (JSA) & Conducting Tool Box Talk (TBT) on daily basics with team members, to ensure Zero Incidents and Accidents
- Successfully Implementation of Electrical LOTO Standards.
Instrumentation Engineer
KCP Sugar And Industries Corporation Limited
12.2007 - 05.2010
- Plant Instrumentation Engineer for 8000 TCD Sugar Plant, 25 MW Cogen Power & 50 KLPD Distillery Plant
- Operation and Maintenance experience of YOKOGAWA DCS (CS1000), SIEMENS S7-400 PLC, WinCC SCADA and 2x100 TPH Boiler @ Kg/cm2 @ 440C
- Operation and Maintenance experience of Electronic Governor of TRISON TS 310 & WOODWARD 505, 505E series and their auxiliaries.
Trainee Instrumentation Engineer
Thandava Cooperative Sugars Limited
06.2007 - 11.2007
- Trainee Engineer (Instrumentation) in Engineering Plant Maintenance Department
- Handling of PID controllers & Control Valves calibrations
Education
Advance Diploma in Industrial Safety Engineering (ADIS) Certification - Industrial Safety (EHS)
Maharashtra State Board of Technical Education, Government of Maharashtra
Mumbai, Maharashtra05.2017
Specialized in Electronics & Instrumentation Engineering - Electronics Control Systems & Instrumentation
Jawaharlal Nehru Technological University
Hyderabad, Telangana05.2007
Skills
- Handling of Life Science Process Equipments from past 10 years
- Experience in Handling of PLC's Like Siemens Simatic, ABB, Allen Bradley, Rockwell Automation, Schneider Modicon, Mitsubishi Melsec & its protocols (Simatic Manager & TIA)
- Experience in Handling of DCS like Siemens PCS7 and Yokogawa CS 1000
- Equipment Qualification Methodology (V Model)
- Life Science Automation & GMP IT Services
- Experience in Total Productive Maintenance (TPM)
- Experience in Regulatory Audits like USFDA, EU GMP MALTA, DRUG CONTROL ADMINISTRATION (KENYA), TFDA (TANZANIA), MOH (OMAN), EUROPEAN MEDICINES AGENCY (EMA),CMO AUDITS
- Project Management (PM)
- Quality Management Systems (QMS),Incident Investigation (II) & Root Cause Analysis (RCA) for failure
- Failure Mode Effects and Critically Analysis (FMECA)
Languages
ENGLISH
HINDI
TELUGU
Personal Information
- Date of Birth: 01/02/1986
- Nationality: Indian
- Marital Status: Married
- Visa Status: Resident
Certification
Certificate of Appreciation from Biocon Biologics
"Go Getter" for exceptional ingenious contribution in meeting functional organizational goals for H1-FY 2023.
First Aid Trainer Certificate
Successful Completion of First Aid Trainer Certificate conducted by Occupational Research Based Institute For Integrated Training (Recognised by Government of Karnataka), Bangalore on May-2023 valid upto May-2026.
Quality Management System (QMS) Internal Auditor Certificate
Successful Completed Quality Management System (ISO 9001: 2008) Internal Auditor Certificate course conducted by TUV NORD, INDIA on January-2014.
Commissioning Testing of SINAMICS S120 VFD in Siemens Limited
Certificate of Participated Training Program, Commissioning of SINAMICS S120 VFD in Siemens Limited, Navi Mumbai, INDIA on January 2012.
Participated in Workshop Program Certification of Preventive Maintenance & Predictive Maintenance at Godrej CII Centre of Excellence, Mumbai on September 2010.
Timeline
Associate Manager (Instrumentation/Automation/CSV)
Biocon Biologics Limited
09.2022 - Current
Senior Executive (Instrumentation & Automation)
National Pharmaceutical Industries Co. (SAOC)
08.2017 - 06.2022
Senior Team Member in Engineering Services
Dr.Reddy's Laboratories Limited FTO SEZ Unit
08.2014 - 08.2017
Engineer in Projects and Maintenance
DRT Anthea Aroma Chemicals Private Limited
03.2012 - 08.2014
Instrumentation Engineer
Siemens Ltd, Kalwa, Thane
06.2010 - 02.2012
Instrumentation Engineer
KCP Sugar And Industries Corporation Limited
12.2007 - 05.2010
Trainee Instrumentation Engineer
Thandava Cooperative Sugars Limited
06.2007 - 11.2007
Advance Diploma in Industrial Safety Engineering (ADIS) Certification - Industrial Safety (EHS)
Maharashtra State Board of Technical Education, Government of Maharashtra
Specialized in Electronics & Instrumentation Engineering - Electronics Control Systems & Instrumentation
Jawaharlal Nehru Technological University
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