Ecofriendly sustainable living
Nirupa Nadella
Group Lead Analytics, Quality Control
SYDNEY
Simplicity is the ultimate sophistication
Summary
Accomplished Quality Control Professional with more than 16 years of experience in the biologics & biotechnology industry. Committed to leading the design, strategy, and implementation of Quality Operations ensuring compliance with all relevant regulations. Seeking an opportunity to join an established team of professionals as a Quality Control Specialist Manager, Head, or Suitable Leadership role, and utilize my knowledge & expertise in operational principles and procedure
Overview
17
17
years of professional experience
7
7
years of post-secondary education
4
4
Languages
1
1
Certificate
Work History
Group Lead - Quality Control
Dr. Reddy's Laboratories
Hyderabad
11.2021 - Current
- Implemented new quality control protocols to consistently meet/exceed production goals with a 30+ member team with timely release of Commercial product batches, while maintaining compliance with regulatory requirements
- Implemented a data-driven approach resulting in a reduction in turnaround time for testing where a Robotic automatic platform was being implemented
- Managed and resolved quality control issues, resulting in a reduction in s and improved testing accuracy and precision, a reduction in the number of deviations, and an increase in overall efficiency
- Employee engagement and retention
- Successful Inspections: MHRA, INVIMA, DCGI, UKRAINE, RUSSIA, QP, CDSCO, ANVISA
- Successfully led the relocation of the laboratory to a new facility without causing any disruption to ongoing activities, ensuring the continuity of operations, and minimizing downtime
- Been a part of the project that received the Chairman Excellence Award for the RI Continuous Fed-Batch project.
Group Lead - Analytical Science and Technology
Dr. Reddy's Laboratories
Hyderabad
01.2016 - 01.2021
- Analyst qualifications Methodology has been put in place
- Establishment & Stabilization of a new team
- End-to-end support for Russia variation filing of Rituximab
- Introducing New technologies into the system
- Tocilizumab clinical campaign closure
- Key support for the approval of Bevacizumab in Russia
- PRI validations for mAbs with Ab coverage studies
- Method harmonization across molecules
- Regulatory support for LCM
- Technology transfer to Russia, Bangladesh
- Been a part of the project that received the Annual Award for the Abatacept project.
Associate Director - Stability and Reference STDS
Dr. Reddy's Laboratories
Hyderabad
01.2015 - 01.2016
- Proposed successful Shelf-life extensions for all commercial products
- Reference standard establishment guidance document.
Manager - Stability and Reference STDS
Dr. Reddy's Laboratories
Hyderabad
01.2013 - 01.2014
- Shelf-life Extension Policy and Stability Policy
- Handled audits (ANVISA, GCC, DCGI, CDCSCO, UKRAINE, RUSSIA, GSK, MERCK), without major observation.
Deputy Manager - Stability and Lot Release
Dr. Reddy's Laboratories
Hyderabad
01.2011 - 01.2012
- Schematized POU studies and, temperature excursions studies for all commercial products
- Managed >200 programs without missing schedules and supporting the regulatory.
Scientist - Analytical Development
Dr. Reddy's Laboratories
Hyderabad
01.2009 - 01.2010
- Developed methods for Polysorbate estimation and IEX using a chromatography platform
- Supported campaign optimizations by providing results for real-time in-process controls.
Assistant Manager - Quality Control
Dr. Reddy's Laboratories
Hyderabad
01.2007 - 01.2009
- Execute testing to support Biologic drug products, method validations, supported unit manufacturing operations by real-time release testing, Transfer of new analytical methods with R&D, QA.
Education
Post Doctoral Fellow - undefined
04.2006 - undefined
Doctor of Philosophy (Ph.D.) - Plant Sciences
08.2001 - 05.2006
Master of Sciences (M. Sc) - Biotechnology
01.1998 - 04.2000
Post Graduate 1 Year Full time Diploma in Computer Applications (PGDCA) - undefined
05.1999 - undefined
Apprenticeship - Genetic Resources and Enhancement Program
05.2001 - 05.2001
Skills
Quality Control and Compliance
Accomplishments
- Implemented new quality control protocols to consistently meet/exceed production goals with a 30+ member team with timely release of Commercial product batches, while maintaining compliance with regulatory requirements
- Implemented a data-driven approach resulting in a reduction in turnaround time for testing where a Robotic automatic platform was being implemented
- Managed and resolved quality control issues, resulting in a reduction in s and improved testing accuracy and precision, a reduction in the number of deviations, and an increase in overall efficiency.
- Employee engagement and retention
- Successful Inspections: MHRA, INVIMA, DCGI, UKRAINE, RUSSIA, QP, CDSCO, ANVISA
- Successfully led the relocation of the laboratory to a new facility without causing any disruption to ongoing activities, ensuring the continuity of operations, and minimizing downtime.
- Been a part of the project that received the Chairman Excellence Award for the RI Continuous Fed-Batch project
- Analyst qualifications Methodology has been put in place
- Establishment & Stabilization of a new team
- End-to-end support for Russia variation filing of Rituximab
- Introducing New technologies into the system
- Tocilizumab clinical campaign closure
- Key support for the approval of Bevacizumab in Russia
- PRI validations for mAbs with Ab coverage studies
- Method harmonization across molecules
- Regulatory support for LCM
- Technology transfer to Russia, Bangladesh
- Been a part of the project that received the Annual Award for the Abatacept project
- Proposed successful Shelf-life extensions for all commercial products
- Reference standard establishment guidance document
- Shelf-life Extension Policy and Stability Policy
- Handled audits (ANVISA, GCC, DCGI, CDCSCO, UKRAINE, RUSSIA, GSK, MERCK), without major observation
- Schematized POU studies and, temperature excursions studies for all commercial products
- Managed >200 programs without missing schedules and supporting the regulatory
- Acted as SPOC internal tech transfers for the CMO projects and the Rituximab external transfer. (Viz., Landsteiner Mexico)
- Lot release system review for optimized and efficient release of commercial products
Publications
- Nirupa N, Transgenic Plant Technology for Remediation of Toxic Metals and Metalloids (ISBN: 978-0-12-8143896),23; Expression of pea seed ferritin gene in indian mustard enhances the accumulation of iron and cadmium.
- Elaine Waldon, Catherine Hellig, Nirupa Nadella, Claus U Pietrzik (2008) LRP1 modulates APP tracking along early compartments of the secretory pathway
- Nirupa N, Prasad MNV, Kirti PB (2009) Expression of pea seed ferritin cDNA in Indian mustard: nutritional value and oxidative stress tolerance of the transformants. In Y. Zhu, N. Lepp and R Naidu (eds). Biogeochemistry of trace elements: Environmental protection, remediation, and human health. Tsinghua University Press. China. pp. 285-286.
- Prasad MNV, Nirupa N (2007) Phytoferritins - Implications for Human Health and Nutrition. The Asian and Australasian Journal of Plant Science and Biotechnology. 11(1): 1-9.
- N. Nirupa, M. N. V. Prasad, S. K. Jami, P. B. Kirti (2007) Optimization of Agrobacterium-Mediated Overexpression of Osmotin-Ferritin Genes in Brassica juncea. Transgenic Plant Journal.
References
References are available on request
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Certification
PMI Agile cerified practitioner
Interests
Feeding Animals
Timeline
Group Lead - Quality Control - Dr. Reddy's Laboratories
11.2021 - Current
Group Lead - Analytical Science and Technology - Dr. Reddy's Laboratories
01.2016 - 01.2021
Associate Director - Stability and Reference STDS - Dr. Reddy's Laboratories
01.2015 - 01.2016
Manager - Stability and Reference STDS - Dr. Reddy's Laboratories
01.2013 - 01.2014
Deputy Manager - Stability and Lot Release - Dr. Reddy's Laboratories
01.2011 - 01.2012
Scientist - Analytical Development - Dr. Reddy's Laboratories
01.2009 - 01.2010
Assistant Manager - Quality Control - Dr. Reddy's Laboratories
01.2007 - 01.2009
Johannes Gutenberg University - Post Doctoral Fellow,
04.2006 - undefined
University of Hyderabad - Doctor of Philosophy (Ph.D.), Plant Sciences
08.2001 - 05.2006
ICRISAT - Apprenticeship, Genetic Resources and Enhancement Program
05.2001 - 05.2001
- Post Graduate 1 Year Full time Diploma in Computer Applications (PGDCA),
05.1999 - undefined
University of Hyderabad - Master of Sciences (M. Sc), Biotechnology
01.1998 - 04.2000
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