Debasish Choudhury
Quality Assurance Professional
Visakhapatnam
Summary
Seeking a challenging and growth-oriented position within an organization to further develop and utilize my skills for success. With a strong foundation of knowledge and experience, I am eager to contribute positively towards achieving personal and company goals. Committed to continuous learning and professional development, striving to make a meaningful impact in a dynamic work environment. Ready to leverage my expertise to maximize opportunities for mutual growth and success.
Overview
17
17
years of professional experience
3
3
Languages
Work History
Deputy Manager in Quality Assurance
AUROBINDO PHARMA LIMITED
02.2015 - Current
Sr. Executive in Quality Assurance
GRANULES INDIA LIMITED
07.2012 - 01.2015
Sr. Executive in Quality Assurance
Dr. Reddy’s Laboratories
01.2010 - 06.2012
Officer in Quality Assurance
Medley Pharmaceutical Limited
07.2008 - 01.2010
Education
Bachelor Of Pharmacy - Pharmaceutical Medicine
Gayatri Institute of Science & Technology
Gunupur, OdishaSkills
IPQA (Manufacturing & Packing)
Interests
Playing Cricket
Watching TV
Listening to music
Dancing
Expertise
Review of weekly and monthly production plan., Ensuring overall document control with respect to cGMP., To monitor issuance, retrieval, archival and control of all master and controlled documents., Preparation SOP’s, Protocols, etc., and reviewing of BMRs, BPRs, MFRs, formats, logbooks etc., Maintenance of documents pertaining to Quality System like change controls, Deviations, FIRs, OOS, OOT & CAPA etc., maintenance and control of master documents, Qualifications and other critical documents., Responsible for maintenance of Archival of the records., Review of all documentation relating to the Manufacturing, Packaging & Analysis reports of each batch of product are complete, accurate and ensure that all work is in full compliance with cGMP, GLP and SOP., Preparation and review of documents (SOP’s, Batch Manufacturing records, Batch Packing Records)., Coordination with RAD for submission of DMF/ANDA/Dossier of products from QA side., Review and approval of new Product codes in ERP & Agile., Review and approval of new equipment, software, server computer numbers., Review and approval of reconciliation details for issued documents., Audit trail review for all software., Certified trainer in functional area and imparting of cGMP training as per schedule., Preparation of training materials, handouts and training modules., Evaluate the participants on the training, follow-up & engage with the participants to ensure the completion of evaluations on time as per schedules., Maintaining & archiving of employee training records & make sure of readiness for auditing at all the times., Giving Line clearance to various manufacturing activities like Liquid bulk preparation, Blending, Encapsulation, Granulation, compression, Coating, Inspection and packing., Monitoring of In-process activities in Oral Liquids & OSD Formulations (Powder & Solid)., Performing of in-process activities such as material verification, start-up, in process checks, AQL and sampling in manufacturing and packing operations., Performing the sampling at different stages of the process as per the sampling plan and approved protocols (if any)., Ensuring online Documentation of manufacturing activities., Reviewing of BMRs, BPRs and ensure the compliance., Identifying the deviations and incidents during the process are reported, investigated and closed., Performing the calibration for the in-process testing equipment’s as per the schedule., Retrieval, Issuance of reserve sample., Ensuring deviations or Non-Conformances observed during the manufacturing and packing activities and identified and documented properly., Review and release of Executed batch records., Review of new change control and disposition of approved Change controls., CAPA verification and closure of incidents., Monitoring of Dispatch Activities., Preparation of major QMS documents like SMF, VMP, etc., Reviewing of SOPs and other major documents of QMS system of the facility management system., Core team member and responsible person for handling of Change Controls, Deviations, CAPA, OOS, OOT, FIRs & Complaints., Ensuring the observed Deviations, OOS, Non-Conformances/observations are properly investigated, documented and closed., Conducting Internal audits for cross functional departments and preparation of reports, follow up of the CAPA and ensuring the adherence to the company procedures & policies., Conducting of periodic management meetings for the cross functional head to enhance the Quality Management System and to take necessary actions required to abide to the Quality Policies., Core member in handling Quality Management System for Handling Change controls, Deviations (Planned and Unplanned), and Incidents/Failures through the Quality Management System., Co-coordinating with other departments to complete the activities and also to implement the CAPAs effectively and periodic checking of CAPAs., USFDA Audit faced for OSD product- in 2011 at DRL & in 2013 at Granules India Ltd., EU-GMP/MMA Audit faced for OSD & Liquid oral product- in 2016, 2019, 2021 & 2024 at APL., Handling of Global/Internal Audits at site., Actively participated in regulatory Inspections like Malta, Russia, ANVISA and several Customer audits from Aurobindo Unit 15., Safety star Cap from QA department., Quality Star Cap from QA department., Support planning and execution of activities related to Documentation Quality Assurance., PMTS implementation at site for Manufacturing (APL)., E-Log implementation at site for Manufacturing (APL)., HMS implementation at site (APL)., DSRS implementation at site (APL)., eBMR trail at site for Manufacturing. (APL), Bachelor of Pharmacy, Gayatri Institute of Science & Technology, B.P.U.T, Gunupur, Odisha, Good Communication and presentation skills., Ability to work hard and to complete the responsibilities in time., Ability to work in-group as well as independently with minimal supervision., Ability to handle multi tasks in single time., Ability to learn new tools quickly., Ability to Communicate and Co-ordinate other departments., Punctuality and hard work to achieve goals., Windows XP, Windows 7, Office 365, MS Office, QMS 6.1v & M7, DMS, EPIQ & DSRS, SAP, Quality Metric stream QMS software, ERP, I hereby declare that the details furnished above are true to the best of my knowledge and belief.
Personal Information
- Date of Birth: 06/02/87
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Addresses
Brundabati Nagar, Near Bypass Road, Gunupur, Odisha, 765022, Palluris Ville, Flat No. 205, Sanivada, Rajeev Nagar Road, Kurmanapalem, Visakhapatnam, Andhra Pradesh, 530046
Timeline
Deputy Manager in Quality Assurance
AUROBINDO PHARMA LIMITED
02.2015 - Current
Sr. Executive in Quality Assurance
GRANULES INDIA LIMITED
07.2012 - 01.2015
Sr. Executive in Quality Assurance
Dr. Reddy’s Laboratories
01.2010 - 06.2012
Officer in Quality Assurance
Medley Pharmaceutical Limited
07.2008 - 01.2010
Bachelor Of Pharmacy - Pharmaceutical Medicine
Gayatri Institute of Science & Technology
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