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Quality by Design at Dr. Reddy's Laboratories
Summary
Chemical Engineer, ASQ Certified Quality Engineer and ASQ Certified Pharmaceutical GMP Professional.
Significant experience in Pharmaceutical manufacturing sites - Drug Substance Scale-up and Technology Transfer, Manufacturing, Quality Management Systems, Lifecycle Implementation of Quality.
Designing Quality into Product Development of Complex Generic Drug Substances & Drug Products currently.
Experience in Continuous Coated Paper and Semi-batch Dye & Pigment Manufacturing.
ASQ Country Counsellor - Switzerland
Key Skills: QbD implementation, Chemical Engineering, cGMP, QMS, Robust Process & Product Design, CMC, Six Sigma, Design of Experiments, Statistical Process Control, Continuous Process Verification, Risk Management, Technical Training.
Improving the Quality of life for customers and in turn businesses, one day at a time.
Significant experience in Pharmaceutical manufacturing sites - Drug Substance Scale-up and Technology Transfer, Manufacturing, Quality Management Systems, Lifecycle Implementation of Quality.
Designing Quality into Product Development of Complex Generic Drug Substances & Drug Products currently.
Experience in Continuous Coated Paper and Semi-batch Dye & Pigment Manufacturing.
ASQ Country Counsellor - Switzerland
Key Skills: QbD implementation, Chemical Engineering, cGMP, QMS, Robust Process & Product Design, CMC, Six Sigma, Design of Experiments, Statistical Process Control, Continuous Process Verification, Risk Management, Technical Training.
Improving the Quality of life for customers and in turn businesses, one day at a time.
https://ch.linkedin.com/in/jasminejasmine
JASMINE WRITES FOR THE MEDICINE MAKER
SEE link https://themedicinemaker.com/
Education
Panjab University
Bachelor of Engineering (B.E.), chemical engineering
Activities and Societies: Member, Student Chapter of IIChE
Experience
Principal Scientist- Quality by Design
Dr. Reddy's Laboratories
Developing diverse complex generic products- right first time. Use of Six Sigma and other Quality Management principles to optimize product development. Ensure life cycle assurance of product quality.
Senior Scientist- Quality by Design
Dr. Reddy's Laboratories
Lead
the Quality by Design facilitation team for Oral Solid Dosage
Development team including Pharmaceutical, Analytical, Packaging, Bio
scientists.
• Create best practices of QbD/ DFSS based development and champion the use of QbD tools like Design of Experiments (DoE), Monte Carlo Simulations (MCS), Artificial Neural networks (ANN), Multivariate Analysis (MVA) and other statistical tools, systematic Risk Assessment tools including FMECA.
• Develop a QbD based Process Validation strategy for Drug Formulations.
• A part of the organization- wide QbD initiative to facilitate QbD across the product lifecycle in Drug Substance and Drug Product Development & Manufacturing.
• Create best practices of QbD/ DFSS based development and champion the use of QbD tools like Design of Experiments (DoE), Monte Carlo Simulations (MCS), Artificial Neural networks (ANN), Multivariate Analysis (MVA) and other statistical tools, systematic Risk Assessment tools including FMECA.
• Develop a QbD based Process Validation strategy for Drug Formulations.
• A part of the organization- wide QbD initiative to facilitate QbD across the product lifecycle in Drug Substance and Drug Product Development & Manufacturing.
Manager- Technology Transfer
Ranbaxy
Process Engineering, Scale-Up, Cost Reduction, Process Intensification:
Responsible for managing the scale-up of chemical processes for generic Active Pharmaceutical Ingredients from the R&D's Laboratory scale to the Manufacturing Plant scale through Kilogram Laboratories and Pilot Plants to deliver robust and safe chemical processes for scale-up, technology transfer and commercial manufacturing.
Quality by Design Implementation:Responsible for managing the scale-up of chemical processes for generic Active Pharmaceutical Ingredients from the R&D's Laboratory scale to the Manufacturing Plant scale through Kilogram Laboratories and Pilot Plants to deliver robust and safe chemical processes for scale-up, technology transfer and commercial manufacturing.
Bridging the gap leading to a QbD way of working for Ranbaxy. Well versed in Chemometrics including Statistical Quality Control tools and Design of Experiments (DoE) and Multivariate Analysis (MVA) with hands-on PAT experience with tools like FBRM, PVM, IR etc.Risk Management Principles and tools like FMECA, HAZOP,etc. for Process and Safety Risk Assessment. Designing the New Process Validation Guideline including Lifecycle Implementation of Quality.
Internal Trainer in QbD, PAT and SPC. Participated in QbD seminars and conferences as a Speaker.
Implementation of Statistical Process Control:
Spearhead the Design and Implementation process of Statistical Process Control for various sites across Ranbaxy.
Graduate Engineer Trainee- Process
Ballarpur Industries Limited
Employed
in Ballarpur Industries Limited (BILT)Unit Bhigwan, Maharashtra: a
state of the art Coated Paper Manufacturing Plant in two profiles:
PRODUCTION: Managed the Off-Machine Coater and responsible for production, maintenance and quality. I managed up to twenty people in my shift directly apart from organizing and coordinating with allied departments. The 1500m/min speed Jagenberg coater capable of manufacturing Art and Chromo papers ranging from 70 to 350 gsm offered me the experience of working with Industrial Control Systems like SCADA, DCS and PLCs. Also involved in Process Intensification, TPM, TQM, 5S and 6 sigma projects.
• PROJECT ENGINEERING:
A part of the Project Team for a brown field project including an online coating machine from Voith Paper, Germany. The $200 million project taught me immensely about Project Engineering and Management. Working on the project with international organizations like Voith, Metso, Jagenberg etc. gave me global exposure to the Paper Industry.
PRODUCTION: Managed the Off-Machine Coater and responsible for production, maintenance and quality. I managed up to twenty people in my shift directly apart from organizing and coordinating with allied departments. The 1500m/min speed Jagenberg coater capable of manufacturing Art and Chromo papers ranging from 70 to 350 gsm offered me the experience of working with Industrial Control Systems like SCADA, DCS and PLCs. Also involved in Process Intensification, TPM, TQM, 5S and 6 sigma projects.
• PROJECT ENGINEERING:
A part of the Project Team for a brown field project including an online coating machine from Voith Paper, Germany. The $200 million project taught me immensely about Project Engineering and Management. Working on the project with international organizations like Voith, Metso, Jagenberg etc. gave me global exposure to the Paper Industry.
Summer Intern
Sudarshan Chemical Industries Ltd.
Environmental Management & Design of Effluent Treatment Facilities in a Dye and Pigment Industry
Certifications
Organizations
Courses
Dr. Reddy's Laboratories
- Level A1 German, Goethe Zentrum, Hyderabad
Volunteer Experience & Causes
Volunteer- API Process Technology
ISPE
With Jasmine , ASQ CQE, CPGP
Quality by Design , PARINCIPAL SCIENTIST at Dr. Reddy's Laboratories, At ACS 2016 — at Dr. Reddys Laboratories , Leadership Academy, Bachupally, Hyderabad.
Quality by Design , PARINCIPAL SCIENTIST at Dr. Reddy's Laboratories, At ACS 2016 — at Dr. Reddys Laboratories , Leadership Academy, Bachupally, Hyderabad.
KNOW Your Speaker - Ms. Jasmine, Senior Scientist, Dr Reddy's Laboratories will deliver a talk on 'Statistics in Product Development- Beyond #DoE' @ QbD in Pharma Development World Congress 2015 #QBDINDIA2015 bit.ly/1wkjvWj scheduled to be held on April 16-18, 2015 — looking for motivation with Pooja Sharma, Tejinder Singh, Shreya Feliz and 16 others at Select Biosciences India.
Late K Anji Reddy, the founder and exChairman of nation's second-largest drugmaker Dr Reddy's Laboratories Ltd,
- Satish Reddy
- G V Prasad
WHOLETIME DIRECTORS
//////////Jasmine, Scientist, Dr Reddy's Laboratories, QBD,
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