Prasad Challapalli
Analytical Research And Development, Quality Control
Hyderabad
Summary
Versatile lead specializing in Analytical R&D and Quality Control (QC) and skilled at planning, implementing and overseeing key improvements to drive business growth and efficiency. History of cultivating an open culture with free exchange of information. Pursuing new professional challenges with a growth-oriented company.
Overview
16
16
years of professional experience
Work History
Senior Manager, AR&D, Quality Control
Alcedo Pharmachem Pvt. Ltd.
04.2024 - Current
- Accountable for Analytical research and development, validations, Technology transfer for commercialization, Quality control technical operations for Complex molecules, Small molecules, Excipient
- Responsible for regulatory approvals ensuring complete compliance of analytical data packages
- Responsible for investigations into OOS (Out of Specification) and OOT (Out of Trend) results, implementing effective CAPA to prevent recurrence, leading to a reduction in lab errors
- Accountable to implement LIMS, QMS in Quality control
- To collaborate closely with peers from other departments to drive organizational success jointly, as one cohesive unit
- To Manage budgets effectively, achieving financial objectives while maintaining strict control over expenditures
- Improved team performance by providing comprehensive training and fostering a collaborative work environment.
- Review and analyze reports, records and directives to obtain data required for planning department activities
Analytical Specialist, AR&D, Quality Control
Dr. Reddy's Laboratories Pvt. Ltd.
09.2017 - 04.2024
- To Develop and validated analytical methodologies for generic, New Chemical Entity (NCE) projects of Peptides, Complex API, small molecules, excipients.
- To Manage analytical technology transfer from R&D to commercial manufacturing sites, ensuring zero-defect compliance.
- To supervise stability studies ensuring compliance with regulatory guidelines
- To reduce QC testing turnaround time through the implementation of automated testing techniques and LIMS, resulting in significant cost savings
- To mange the teams from Analytical R&D, Validations, Quality control
- To Collaborate closely with peers from other departments to drive organizational success jointly as one cohesive unit
- Responsible to assist the customer and regulatory deficiency queries
- To Manage budgets effectively, achieving financial objectives while maintaining strict control over expenditures
Scientist-II, Analytical
United States Pharmacopeia (USP)
07.2015 - 09.2017
- To develop and validated analytical methodologies for Peptides, Proteins, Excipient
- To develop, modernize monograph, General chapters
- To evaluate the reference standards
- To ensure GLP activities, laboratory safety management
- Implemented quality control measures to ensure the accuracy and reliability of experimental results
- Trained new employees on areas of technical expertise and compliance issues relevant to lab setting
Executive, AR&D, Quality Control
Auropeptides Pvt. Ltd.
02.2013 - 06.2015
- To Develop and validated analytical methodologies for generic, New Chemical Entity (NCE) projects of Peptides
- To Manage analytical technology transfer from R&D to commercial manufacturing sites, ensuring zero-defect compliance
- To establish the new laboratory facility
- To supervise stability studies ensuring compliance with regulatory guidelines
- To reduce QC testing turnaround time through the implementation of automated testing techniques and LIMS, resulting in significant cost savings
- Responsible for investigations into OOS (Out of Specification) and OOT (Out of Trend) results, implementing effective CAPA to prevent recurrence, leading to a reduction in lab errors
- To Collaborate closely with peers from other departments to drive organizational success jointly as one cohesive unit
- Mentored junior staff members for accelerated career growth, developing future leaders within the organization.
Chemist, Quality Control
Ecologic Chemicals
08.2011 - 02.2013
- To perform the testing , release of raw materials, in-process, intermediate, finished products
- To prepare the documentation, STP, GTP, SOP, Protocols
- To execute the analytical method validations
- To perform the stability testing of API
- Responsible for investigations into OOS (Out of Specification) and OOT (Out of Trend) results, implementing effective CAPA to prevent recurrence, leading to a reduction in lab errors
- To Collaborate closely with peers from other departments to drive organizational success jointly as one cohesive unit
- Performed technical laboratory functions in compliance with regulatory agencies and safety requirements.
Chemist, Quality Control
Synergene Active Ingredients
02.2010 - 08.2011
- To perform the testing , release of raw materials, in-process, intermediate, finished products
- To prepare the documentation, STP, GTP, SOP, Protocols
- Coordinated and performed analytical tests to comply with established standards and specifications.
Education
Master of Science - Analytical Chemistry
Andhra University
Visakhapatnam 04.2001 -
Bachelor of Science - Maths, Physics, Chemistry
Miriam College, Andhra University
Amalapuram 04.2001 -
Skills
R&D & Quality: Analytical Method Development (AMD), Method Validation, Stability Studies, Technology Transfer, Regulatory Submissions, Quality testing and release
Compliance & Systems: GMP/GLP, Regulatory Audits, LIMS, QMS, CAPA, Root Cause Analysis
Leadership: Strategic Planning, Team Mentorship, Budget Management (Cost-Center Management), Cross-functional Collaboration
Analytical Techniques: HPLC, UPLC, GC, LC-MS/MS, IC,TLC, CE, NMR, UV-VIS, DSC, TGA, XRD,FTIR,AAS, ICP-MS, CE, GPC, Wet Chemistry
Accomplishments
- Established new AR&D lab, Quality control lab, Quality standards successfully in Alcedo Pharmachem Pvt.Ltd.
- Awarded for successful establishment of the LIMS application, for outstanding Analytical support in DMF activities, experienced the USFDA audit in Dr.Reddy's laboratories
- Demonstrated the analytical techniques, related substances by HPLC for peptides, Peptide mapping by HPLC for the ISO certification in 2016 in USP
- Successfully established the Analytical laboratory facility, completed EDQM audit in Auropeptides
- Awarded as the best quality control associate In Ecologic chemicals
Timeline
Senior Manager, AR&D, Quality Control
Alcedo Pharmachem Pvt. Ltd.
04.2024 - Current
Analytical Specialist, AR&D, Quality Control
Dr. Reddy's Laboratories Pvt. Ltd.
09.2017 - 04.2024
Scientist-II, Analytical
United States Pharmacopeia (USP)
07.2015 - 09.2017
Executive, AR&D, Quality Control
Auropeptides Pvt. Ltd.
02.2013 - 06.2015
Chemist, Quality Control
Ecologic Chemicals
08.2011 - 02.2013
Chemist, Quality Control
Synergene Active Ingredients
02.2010 - 08.2011
Master of Science - Analytical Chemistry
Andhra University
04.2001 -
Bachelor of Science - Maths, Physics, Chemistry
Miriam College, Andhra University
04.2001 -
DECLARATION:
I hereby declare that the above-mentioned information is true and authentic to the best of my knowledge. Date: Place: Hyderabad (Prasad Challapalli)