Shravan Prabhu
Sanquelim
Summary
Driven engineering professional with a robust background in quality management systems and computerized system validation, honed at Fresenius Kabi India Private Limited. Excelled in enhancing compliance and operational efficiency through technical writing and result oriented thinking Demonstrated leadership in training teams and streamlining processes, achieving significant improvements in equipment reliability and maintenance.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Officer-Engineering
Puniska Injectables Private Limited
08.2022 - Current
- Preparation and review of documents such as URS,FAT,SAT,DQ,IQ and PQ of systems and equipments
- Responsible for executing and monitoring all the activities related to incident deviation,change control,risk assessment,root cause identification and CAPA
- Compliance team member for computerized system validation as per 21 CFR part 11,EU annex 11 and GAMP 5
- Preparation of Standard operating procedure for plant equipment and systems
- Responsible to activities related to audit compliance
- Imparting training to subordinate on required topics
Sr.Supervisor-Engineering
Fresenius Kabi India Private Limited
08.2020 - 08.2022
- Preparation of URS,FAT,SAT,DQ,IQ,OQ and PQ of engineering projects
- Preparation of standard Operating Procedure for plant equipment and systems
- Creation,tracking and updating schedule of Preventive Maintenance of plant equipment and calibration of equipment
- Preparing periodic reports of equipment performance,production volume and analysis
- Preparation of KPI analysis and reporting on software Resource advisor
- Executing necessary tasks required for incident deviation and change control on software Kabitrack(trackwise)
- Ensuring routine execution of work permit and waste management in the plant
- conducting periodic training and drill in the plant
Officer-plant Maintenance
Otsuka Pharmaceuticals India Private Limited
02.2020 - 08.2020
- Preventive and breakdown maintenance of BFS machines,Sterilizers and packing machineries etc.
- Ensuring proper operation of WFI and RO plants
- Preparation of Standard operating procedures and qualification documents
- Implementation team member of software platform DMS(Document Management System) for engineering department
- Preparing schedule of periodic preventive maintenance and supervising subordinate teams of execution
- Preparing daily equipment breakdown reports and analysis
Supervisor-Engineering
Fresenius Kabi India Private Limited
10.2015 - 01.2020
- Operation of BFS machines
- Preventive and breakdown maintenance of BFS machines and plant equipment
- Archiving organization target by effective handling of machines
- optimum usage of plastic and other resources in the plant
- ensuring safe work practices at work place as per personal and environmental safety
Education
Bachelor of Engineering - Electrical And Electronics
Haliyal,Karnataka07.2015
Higher Secondary School - Science
Pre University Education Board,Karnataka
Sirsi, India06.2008
Secondary School -
BCPU Collage
Gokarna,Karnataka06.2006
Skills
- Quality Management system
- Computerized system validation
- MS office
- Trackwise
- DMS
- SAP
- Technical writing
Accomplishments
Received the award "Employee of the year " 2017 at Frsenius Kabi India Private limited
Certification
Certification in Computerized system Validation by company connect institute
Additional Information
Good understanding of guidelines such as 21 CFR part 11, EU annex 11 and GAMP 5 and their application, importance in Computerized system Validation
Languages
English
Bilingual or Proficient (C2)
Hindi
Upper intermediate (B2)
kannada
Bilingual or Proficient (C2)
Marathi
Upper intermediate (B2)
Konkani
Upper intermediate (B2)
Spanish
Elementary (A2)
Timeline
Officer-Engineering
Puniska Injectables Private Limited
08.2022 - Current
Sr.Supervisor-Engineering
Fresenius Kabi India Private Limited
08.2020 - 08.2022
Officer-plant Maintenance
Otsuka Pharmaceuticals India Private Limited
02.2020 - 08.2020
Supervisor-Engineering
Fresenius Kabi India Private Limited
10.2015 - 01.2020
Bachelor of Engineering - Electrical And Electronics
Higher Secondary School - Science
Pre University Education Board,Karnataka
Secondary School -
BCPU Collage
Certification in Computerized system Validation by company connect institute
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