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Amlan Ghosh
Quality Assurance Executive
Navi Mumbai
Summary
Executive in Quality Assurance with 3 years of experience in Quality Management System in Bio-Pharmaceutical industry. Expertise in the development, implementation, and integration of quality systems. Managing all QA and QMS activities/requirements, also interpret user problems and suggest appropriate system change proposals to correct defects and enhance system functionality and performance.
Overview
3
3
years of professional experience
1
1
Certification
3
3
Languages
Work History
Quality Assurance Executive
Reliance Life Sciences Pvt Ltd
02.2024 - Current
- Handling of QMS elements: Deviations, Change controls, CAPA implementation, OOS investigations.
- Preparation, review, publish, archival of SOPs and other documents in Document Management System (DMS).
- Involving to the investigations related to the non-compliances.
- To help in preparation of Audit Reports and any impact assessments.
- Issuance, review, maintenance of BMR, MFR and other Study protocols etc.
- Batch Release, COA generation, Batch disposition in Laboratory Information Management System (LIMS).
- Handling and reviewing of parameters related to manufacturing in MES PAS-X and ensure line clearance procedure during manufacturing & at all stages of monitoring.
- Compilation of Annual product Quality Review as per year wise.
- Monitor shop floor activities and report non-compliance in terms of deviations, or any incident that may have a direct adverse effect on quality of a product, system and facility.
- Verification and approval of Dispensing of Raw Material, hand over the product from Store to Production.
- Providing cGMP & SOP trainings.
- Reviewing Monthly Audit Trail Data for equipment's and Logbooks of Various areas.
- Support in data collection.
Quality Assurance Executive
Biocon Biologics Limited
05.2022 - 02.2024
- Review & Approval of Master and executed BMR, PDR, SOP, Study protocol & reports, MFR, APQR, YBPR etc.
- Handling of QMS elements: Deviations, OOS and OOT, OOct, Change controls, assist in CAPA implementation.
- Handling of continuous process monitoring in Minitab.
- Assessment of IPQA related change controls to assure proper impact assessment to develop and maintain quality.
- Provide support to enhance the efficiency of internal audits, identify key improvement areas.
- Monitor shop floor activities and report non-compliance.
- Create, review and approve Good Manufacturing Practices audit reports and provide feedback and guidance on corrective and preventive actions.
- Providing cGMP & SOP trainings.
- To ensure line clearance procedure during manufacturing & packing operation at all stages, monitoring, providing inputs for sampling and dispatch activities.
- Reviewing and approving SAP approvals where were required in the process.
- Reviewing Monthly Audit Trail Data for equipment's and Logbooks of Various areas.
- Support in data collection.
Education
M.Sc. - Microbiology
University of Kalyani
Kalyani, West Bengal 08.2019 - 9 2021
B.Sc. - Microbiology (Hons)
Kalyani Mahavidyalaya
Kalyani, West Bengal 07.2016 - 7 2019
Higher Secondary - undefined
Karimpur Jagannath High School
Karimpur, West Bengal 01.2015 - 1 2016
Secondary - undefined
Karimpur Jagannath High School
Karimpur, West Bengal 01.2013 - 1 2014
Skills
Teamwork
Certification
BITS-BIOCON certificate program in Applied Industrial Microbiology, Biocon Academy, Bangalore, 03/01/22 - 05/01/22
Training
- Offline Training on 'From Animal cell culture to studying the gene expression', 12/20/21 - 01/28/22, University of Kalyani, West Bengal
- Advanced Online Workshop on Molecular Docking, 09/01/20, IIIT Allahabad
- Online skill Development Program in Advanced Biotech Techniques, 09/01/20, MRD Lifesciences, Lucknow
Disclaimer
I hereby declare that all statements made in this application are true, complete, and correct to the best of my knowledge and belief.
Personal Information
- Father's Name: Arup Kumar Ghosh
- Date of Birth: 07/04/99
- Nationality: Indian
- Marital Status: Unmarried
Interests
Timeline
Quality Assurance Executive
Reliance Life Sciences Pvt Ltd
02.2024 - Current
Quality Assurance Executive
Biocon Biologics Limited
05.2022 - 02.2024
M.Sc. - Microbiology
University of Kalyani
08.2019 - 9 2021
B.Sc. - Microbiology (Hons)
Kalyani Mahavidyalaya
07.2016 - 7 2019
Higher Secondary - undefined
Karimpur Jagannath High School
01.2015 - 1 2016
Secondary - undefined
Karimpur Jagannath High School
01.2013 - 1 2014
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