Bhanu Prakash
Pune
Summary
Dedicated and highly motivated professional with more than 10 Years of experience in pharmaceutical industry with strong technical knowledge and expertise in the Computerized System Validation (CSV), Equipment Qualification & Commissioning and compliance.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Senior Consultant- Business Consulting
Infosys consulting
Pune
02.2024 - Current
- Working for global pharmaceutical clients as a Project Quality Manager/Validation Lead.
- Manages and coordinates end-to-end global CSV/IT projects.
- Help the client finalize the validation strategy based on system classification, complexity, and after analyzing scenarios in the case of upgrades, migrations, enhancements, etc.
- Create validation plan and guide the project team to generate software life cycle deliverables according to system complexity and risk classification.
- Review software life cycle deliverables, like HLCCD, URS, CS, FS, FRA, test plan, test scripts, test executions, RTM, VSR, data migration plan/report, and periodic review.
- Day-to-day working experience on various applications like HP ALM, ServiceNow (for change requests, incidents, deviations), Veeva QualityDocs, Jira, etc.
Validation Lead - CSV
Billennium Limited
Pune
05.2022 - 02.2024
- Company Overview: Worked for global pharmaceutical clients as a Project Quality Manager/Validation Lead.
- Manages and coordinates end-to-end global CSV/IT projects.
- Help the client finalize the validation strategy based on system classification, complexity, and after analyzing scenarios in the case of upgrades, migrations, enhancements, etc.
- Create validation plan and guide the project team to generate software life cycle deliverables according to system complexity and risk classification.
- Review software life cycle deliverables, like HLCCD, URS, CS, FS, FRA, test plan, test scripts, test executions, RTM, VSR, data migration plan/report, and periodic review.
- Day-to-day working experience on various applications like HP ALM, ServiceNow (for change requests, incidents, deviations), Veeva QualityDocs, Jira, etc.
CSV Team Lead - CSV (Pharmaceutical -IT)
Lupin Limited
Mumbai
06.2020 - 05.2022
- Plan, manage, and coordinate validation activities across Lupin sites in India.
- Lead the CSV team for software validation (standalone, client-server based, and enterprise application).
- Set up a globally recognized CSV framework across Lupin sites.
- Prepare SOPs and train the users.
- Successfully implemented SAP S/4 HANA.
- Support in handling regulatory audits, like the USFDA, MHRA, WHO, etc.
Executive- Corporate Quality Assurance (CSV)
Mankind Pharma Limited
New Delhi
02.2019 - 05.2020
- Plan, manage, and coordinate validation activities across Mankind sites in India.
- Excellent experience in the execution of computer system validation of laboratory systems, such as FTIR, UV, GC, CHNS, HPLC, TGA, DSC, PXRD, dissolution apparatus, Mastersizer 3000, Chromeleon, LABX, LabSolutions, Empower, SDMS, etc.
- Responsible for conducting audits of GxP systems at different sites.
- To onboard and train validation consultants, and to assure thoroughness of validation planning while making appropriate progress towards the timely completion of validation deliverables.
- Draft CSV and IT SOPs, and train the users.
- Support in handling regulatory audits, such as the USFDA, MHRA, WHO, etc.
Sr. Officer- Manufacturing (Pharmaceutical Technical Services)
Alkem Laboratories Limited
Baddi
01.2018 - 02.2019
- Plan and execute validation of manufacturing equipment.
- To ensure manufacturing compliance at the site.
- Excellent experience of conducting computer system validation and qualification of pharmaceutical manufacturing equipment, such as compression machines, Wurster coaters, blenders, packaging equipment, and coating machines.
- To onboard and train validation consultants, and to assure thoroughness of validation planning while making appropriate progress towards the timely completion of validation deliverables.
- Expertise in the validation of manufacturing software such as Glattview, SAWC, WINCC, Ellipse, Zenon, Vijeo Designer, and E-Designer.
- Expertise in PLC validation.
- Working knowledge of Quality Management System (ServiceNow, Documentum, Caliber, TrackWise, SAP).
Officer – Equipment Qualification & Validation (Pharmaceutical Manufacturing Services)
Mylan Laboratories Ltd (Viatris)
Nashik
08.2014 - 01.2018
- Plan and execute validation of manufacturing equipment.
- To ensure manufacturing compliance at the site.
- To onboard and train validation consultants, and to assure thoroughness of validation planning while making appropriate progress towards the timely completion of validation deliverables.
- Excellent experience in computer system validation and qualification of pharmaceutical manufacturing equipment, such as compression machines, Wurster coaters, blenders, packaging equipment, and coating machines.
- Expertise in the validation of manufacturing software such as Glattview, SAWC, WINCC, Ellipse, Zenon, Vijeo Designer, and E-Designer.
- Expertise in PLC validation.
- Working knowledge of Quality Management System (ServiceNow, Documentum, Caliber, TrackWise, SAP).
Education
Masters of Pharmacy - Pharmaceutics
Birla Institute of Technology
Ranchi, Jharkhand, India05-2014
Bachelor of Pharmacy -
SHIATS
Allahabad, India05-2012
Intermediate -
Annada College
Hazaribagh, Jharkhand, India04-2005
Skills
- Manufacturing Systems
- Laboratory Systems
- ERPs
- Strong leadership skills
- SOP development
- CAPA management
- Quality auditing
- Computer system validation
- Equipment qualification
- GMP auditing
- Change control
- Data integrity
- HPALM
- Trackwise
- Service Now
- Jira
Certification
- Qualified GATE-2012 (All India Rank-298).
- Completed General course on Intellectual property conducted by WIPO Worldwide Academy in 2010 with 94%.
- Awarded by merit certificate during B. Pharm (2008-2012).
- Poster presentation on 'Development and Optimization of Tamoxifen Citrate Loaded Nanospheres and Nano capsules Using Response Surface Methodology' at IAPST International Conference held at Jadavpur University, Kolkata (01/17/14 to 01/19/14).
- Poster presentation on 'Green chemistry' at SHIATS Allahabad in 2009.
- Participated in 'SIPSA-09' at Sambhunath institute of technology, Allahabad.
- Participated in 'Rendezvous-09' during national pharmacy week at united group of institution, Allahabad in 2009.
Extracurricular Activities
- Responsible & sincere member of 'National Service Scheme' (NSS) during graduation & Participated in Various Programs like Family Planning, Awareness about Diabetes.
- Got primary training in 'Bharat scouts and guides' during schooling period.
- Member of Editorial Board of 'PHARMBIT' an international Journal by Dept. of pharmaceutical Sciences and Technology, BIT, Mesra, Ranchi.
Disclaimer
I do hereby declare that the above information is true to the best of my knowledge.
Languages
- English
- Hindi
Personal Information
- Relocation: Willingness to relocate both Domestic & International.
- Date of Birth: 12/07/88
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Timeline
Senior Consultant- Business Consulting
Infosys consulting
02.2024 - Current
Validation Lead - CSV
Billennium Limited
05.2022 - 02.2024
CSV Team Lead - CSV (Pharmaceutical -IT)
Lupin Limited
06.2020 - 05.2022
Executive- Corporate Quality Assurance (CSV)
Mankind Pharma Limited
02.2019 - 05.2020
Sr. Officer- Manufacturing (Pharmaceutical Technical Services)
Alkem Laboratories Limited
01.2018 - 02.2019
Officer – Equipment Qualification & Validation (Pharmaceutical Manufacturing Services)
Mylan Laboratories Ltd (Viatris)
08.2014 - 01.2018
- Qualified GATE-2012 (All India Rank-298).
- Completed General course on Intellectual property conducted by WIPO Worldwide Academy in 2010 with 94%.
- Awarded by merit certificate during B. Pharm (2008-2012).
- Poster presentation on 'Development and Optimization of Tamoxifen Citrate Loaded Nanospheres and Nano capsules Using Response Surface Methodology' at IAPST International Conference held at Jadavpur University, Kolkata (01/17/14 to 01/19/14).
- Poster presentation on 'Green chemistry' at SHIATS Allahabad in 2009.
- Participated in 'SIPSA-09' at Sambhunath institute of technology, Allahabad.
- Participated in 'Rendezvous-09' during national pharmacy week at united group of institution, Allahabad in 2009.
Masters of Pharmacy - Pharmaceutics
Birla Institute of Technology
Bachelor of Pharmacy -
SHIATS
Intermediate -
Annada College
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