Somnath Roy
Senior Executive -Manufacturing Of Sterile Injectables
Hooghly
Summary
As a Performance-driven Pharmacy professional with 5 years 9 months of experience in injectable formulation manufacturing with cGMP compliance and regulatory requirements.
As an individual Passionate about execution excellence with Quality attribute and extremely motivated to implement my technical skills and knowledge for the commercial success of the organization.
As a results-oriented team player I always believed in teamwork & try to be a catalyst for the team’s Success.
Overview
6
6
years of professional experience
47
47
years of post-secondary education
Work History
Senior Executive
Biocon Biologics
Bangalore
05.2020 - Current
- Biosimilar Manufacturing of Drug Product
- Supervisor of Aseptic operation
- Operations of Aseptic Process Stimulation
- Supervisor of Autoclave & load Preparation
- Conducting Commissioning & Qualification of Autoclave & Parts washer.
- Validation exercise of Autoclave and Parts washer.
- Preparation of SOP, study protocol & Report.
- Handling of QMS Tools (Change Control, Deviation & investigation, CAPA, Risk assessment)
- Provide the training of SOP, Protocol and awareness of GDA & Data Integrity.
- Active involvement for implementing path-breaking Digitization Goal Of Paperless Validation (EVLMS) system across BBL.
- implementation of 5 S Principle in manufacturing shop floor
- Aligned organizational objectives with company mission to increase business growth and integrate work strategies.
Sr. Executive
CIPLA
Verna
10.2019 - 04.2020
- Hormone Prod
- Autoclave
- Aseptic Practice
- Vial-filling Machine
- QMS Doc
- Validation/Qualification
- Audit exposure
- Carrying out the batch Processing activities with safety, cGMP & as per SOP
- Preparation of SOP, study protocol and Qualification documents
- Qualified trainer and Supervisor of Component Autoclave and aseptic processing
Sr. Associate
Liva Pharmaceutical Ltd, Zydus Group
Vadodara
11.2016 - 09.2019
- Supervised the aseptic area and vial filling process
- Conducting Qualification & Validation exercise of VHP and Parts washer machine
- Implement RFID based Garments Tracking system
- Handling of QMS Tools (Change Control, Deviation & investigation, CAPA, Risk assessment and microbial excretion report.
Education
Pharmacy
West Bengal University of Technology (WBUT)
01.2013 - 01.2016
Pharmacy
State medical faculty of West Bengal
01.2011 - 01.2013
10+2 Higher Secondary - undefined
West Bengal Council of Higher Secondary
01.2009 - 01.2011
10th - Secondary Education
West Bengal Board of Secondary Education
02.1969 - 01.2009
Skills
EQUIPMENT HANDLEDundefined
Timeline
Senior Executive
Biocon Biologics
05.2020 - Current
Sr. Executive
CIPLA
10.2019 - 04.2020
Sr. Associate
Liva Pharmaceutical Ltd, Zydus Group
11.2016 - 09.2019
Pharmacy
West Bengal University of Technology (WBUT)
01.2013 - 01.2016
Pharmacy
State medical faculty of West Bengal
01.2011 - 01.2013
10+2 Higher Secondary - undefined
West Bengal Council of Higher Secondary
01.2009 - 01.2011
10th - Secondary Education
West Bengal Board of Secondary Education
02.1969 - 01.2009
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