Sushanta Kumar Jena
Bangalore
Summary
To be best in my field and contribution significantly in the process of the organization by being part of its strategy and implementation process. To get responsible position in an environment demanding corporate growth and dynamic working skills, that allows me to utilize my education experience creativity.
Experience in Production, handling of Production Documentation, Batch Execution, Equipment qualification, Document preparation, Change controls, Deviation & Investigations and ERP, Dispatch activity.
Overview
12
12
years of professional experience
Work History
Production Asst Manager
Hikal Ltd
Bangalore
04.2015 - Current
- Preparation of daily production report
- Preparation of production target and achievements as per dispatch schedule
- To monitor production as well as safety activities
- Overall responsibility for process activities, manpower handling, proposals, troubleshooting of all kinds problems
- Pre-auditing the production plant
- Conducting review of regulatory documents and assures they meet the cGMP and regulatory requirement
- Initiating change control and closing assigned CAPA
- Preparation of new BPCR as per the R&D team and MFC for new products
- Involving in the preparation of the BPCR, BCLR, PDR & MCLC of new equipment
- Carry out the operations as mentioned in the BPCR/SOP
- Checking of Raw Materials for availability/quantity/quality details
- Maintaining cGMP practices and Good documentation practices
- Preparation of SOPs and various types of protocol
- Equipment handled like Reactors (SSR, GLR), Rotocone vacuum drier, Agitated Nutsche filter, Centrifuges (bottom discharge and Bag lifting), Sparkler filter & micron filter, Multi mill, Sifter, Metal detector, PTS system
- Coordinating with Quality Control, Quality Assurance and Microbiology
- Faced regulatory audits such as USFDA, PMDA, WHO and several customer audits
- Involving in the preparation and execution of the equipment Qualifications and Re-Qualification Program
- Handling of the QMS related documents like change controls, Deviation, investigations of OOT, OOS and market complaints
Trainee
Vidya Harbs Pvt Ltd
Bangalore
06.2013 - 03.2015
Education
M.Sc. - CHEMISTRY
KUVEMPU UNIVERSITY
Karnataka01.2016
B.Sc. - CHEMISTRY
R.I.H.S College
Bhograi, Balasore, Odisha01.2011
12TH -
R.I.H.S College
Bhograi, Balasore, Odisha01.2008
10TH -
S.M. High School
Balharpur, Odisha01.2006
Skills
- Basics in computer
- MS Office
- Excel
- PowerPoint
- ERP
- Batch creation
- Raw material entry
- Batch closing in ERP
Accomplishments
- Spot Award for contribution towards proactively coordinated for documentation work during capacity enhancement.
- Spot Award for contribution towards proactively involved in troubleshooting issues related to PTS.
- Spot Award for contribution towards coordinated well during Low Chloride Gabapentin manufacturing for Pfizer & Pharma science.
- Spot Award for contributed in an extraordinary manner during USFDA Audit.
- Spot award for highest Gabapentin production.
- Spot award for on-time delivery to customers with effective plan.
- Spot award for achieving 97.6 MT of Gabapentin & timely dispatch.
- Spot award for increasing of production yield.
- Employee of the month award for worked with crystallization & pparea team to implement plans to achieve the physical parameters of product like (PSD, BD, TD).
- Achieve various competition prize like essay, skit, elocution, quiz on celebration of safety week.
Languages
- English
- Hindi
- Kannada
- Odia
Disclaimer
I hereby declare that the above information furnished is true to the best of my knowledge and belief.
Personal Information
- Date of Birth: 02/16/91
- Gender: Male
- Nationality: Indian
- Marital Status: Single
Trainingprograms
- All cGMP programs
- First aid & Fire Fighting
- General safety rule
- Data integrity & Good Documentation practices
- Process Validation & cleaning Validation
- Increase productivity & time management
- LAKSHYA – The Catalyst for Change Hikal Leadership Development
- Operational Excellence training including 5S Methodology, Six Sigma & Kaizen
Timeline
Production Asst Manager
Hikal Ltd
04.2015 - Current
Trainee
Vidya Harbs Pvt Ltd
06.2013 - 03.2015
M.Sc. - CHEMISTRY
KUVEMPU UNIVERSITY
B.Sc. - CHEMISTRY
R.I.H.S College
12TH -
R.I.H.S College
10TH -
S.M. High School
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