NIRMALYA DASGUPTA
Sr. GM Quality
BANGALORE
Summary
Accomplished Senior Quality Assurance Consultant with a proven track record at Syngene International, enhancing quality management systems and leading regulatory affairs. Expert in implementing QMS software and driving continuous improvement initiatives. Certified Lead Auditor and Green Belt Six Sigma, demonstrating exceptional leadership and analytical skills. Achieved significant efficiency improvements and fostered key industry partnerships for mutual growth.
Overview
39
39
years of professional experience
1
1
Language
Work History
Senior Quality Assurance Consultant
Syngene International
09.2018 - 07.2024
- Drove Quality management systems for Bulk Drugs, Formulations, Biologics.
- Drove Regulatory inspections like FDA, EMA, MHRA, Russia, Indian Drug authorities.
- Instrumental in implementing various QMS software like LMS, EDMS, Trackwise.
- Drove Internal Quality audit function including compliance to CSV.
- Conducted detailed root cause analysis to identify recurring issues and recommend corrective actions for long-term resolution.
- Effectively utilized data-driven insights to guide prioritization efforts during various stages of software development.
- Championed the use of cutting-edge tools and technologies within the QA team, resulting in increased productivity and innovation.
- Drove continuous improvement initiatives within the organization by analyzing existing processes for inefficiencies or gaps that could be addressed more effectively.
- Drove Risk identification and mitigation plans.
- Led Regulatory affairs team.
Sr Director Quality
Dr Reddys
03.2015 - 09.2018
- Created an agile working environment, enabling rapid response to changing business needs without sacrificing quality or performance standards.
- Developed strong relationships with key industry partners, fostering collaboration and mutual growth opportunities.
- Directed design and execution of business transformation initiatives to drive performance, profit optimization and growth opportunities.
- Audit Complaince activities
- Create a single source of information on audit readiness activities from multiple sources API and Formulations.
- CAPA management process across all sites Establish fast pace execution of CAPA & highlight issues & expedite decision making Support in Engineering and Infrastructure compliance.
- GXP IT ( 21CFR : Part 11) compliance Periodic sustenance check for GMP Compliance. Implement learnings across sites to ensure harmonized quality compliance
- Compliance of Regulatory observations coming from other companies in the industry. Compliance to Regulatory updates from different agencies like MHRA, FDA. Support for engineering excellence to comply GMP. Facilitating Quality Ombudsperson process for the company
QA Manager
Reckitt Benckiser
12.1985 - 08.2015
- Improved overall efficiency of the QA department through strategic planning and resource allocation.
- Managed cross-functional teams to ensure seamless coordination between QA, development, and support departments.
- Audit & Compliance activities GMP audit. Ensuring timely implementation of corrective/Preventive actions and continuous improvement.
- Quality Culture building
- Setting GLP Standards in laboratory in line with global and statutory requirement.
- SQC implementation at shop floor
- Risk Analysis, OOS/ OOT, Incident review and action through systemic robust investigations process, impact assessment and execution of appropriate CAPA related to Incidents, OOS, OOT and market complaints
- QA Release of Finished products
- Validation activities.
- Vendor Development and Vendor Audits
- Quality Trend analysis and actions.
- Cost savings and improve Gross margin.
Education
Certification in Production Management
Indian Institue of Management, Kolkata
KolkataBachelor of Pharmacy - Pharmaceutical Sciences
Jadavpur University
Kolkata, India 04.2001 -
Skills
IRQA UK- Certified Lead Auditor, ISO 9000 Quality System
DNV: Internal Auditor certification QMS and ISO 14000
Green Belt Six Sigma certified
Certification on New Horizon Leadership programme: A flagship Leadership programme to work towards increasing the effectiveness of individuals and build leadership ability
Space science
Explore the mysteries of the universe provides me endless opportunities for discovery. It sparks curiosity about planets, stars, and galaxies, while also fostering an appreciation for the vastness of space and the advancements in space exploration.
Timeline
Senior Quality Assurance Consultant
Syngene International
09.2018 - 07.2024
Sr Director Quality
Dr Reddys
03.2015 - 09.2018
Bachelor of Pharmacy - Pharmaceutical Sciences
Jadavpur University
04.2001 -
QA Manager
Reckitt Benckiser
12.1985 - 08.2015
Certification in Production Management
Indian Institue of Management, Kolkata
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