Rajasekhar Rathikrinda
Ahmedabad
Summary
Results-driven Executive specialising in injectable formulation development. Led strategic initiatives to enhance product integrity and ensure regulatory compliance. Managed investigations and documentation for successful product transitions while fostering a collaborative work environment. Strong communicator and problem-solver, committed to driving operational efficiency and contributing to organisational growth.
Overview
3
3
Languages
11
11
years of professional experience
Work History
Executive
Torrent Research centre
Ahmedabad , India
06.2025 - Current
- Executed developmental activities for injectable formulation products, improving product quality and ensuring regulatory compliance.
- Execute the Design of experiments,AMV batches,scale up and validation batches at the commercial GMP facilities.
- Conducted DOE (design of experiments) using QBD principles, including pre- reformulation studies, establishing C MA's and CPP's and CMAs
- Prepared MFCs, in-process sampling plans, and specifications for in-process, semi-finished, and finished products to support product quality assurance.
- Prepared documentation for Demonstration batches protocols, Finalised reports for izing the inprocess and SFG and FG test parameters as per regulatory requirements.
- Initiated OOS/OOT through QMS systems and prepared investigation reports based on stability study observations to address compliance issues.
Junior Manager
MSN laboratories limited
Hyderabad
08.2023 - 05.2025
- Conducted DOE (design of experiments) using QBD principles, including pre- reformulation studies, establishing CMAs and CPPs and CMAs
- Execute the Design of experiments,AMV batches,scale up and validation batches at the commercial GMP facilities.
- Executed developmental activities for injectable formulation products, resulting in improved product quality and compliance.
- Prepared documentation for demonstration batch protocols and finalised reports on in-process, semi-finished, and finished product test parameters as per regulatory requirements.
- Preparation of MFCs, In-process sampling plans ISPs,specifications for in-process, semi-finished, and finished products.
- Commenced investigations for OOS/OOT results using QMS systems and prepared investigation reports based on stability study observations.
Senior executive
Shilpa medicare Limited
Jadcherla
04.2018 - 07.2023
- Accountable leadership guided transfer of new sterile injectable products to commercial manufacturing.
- Directed end-to-end product alignment from gap analysis through scale-up execution.
- Governed sterility assurance criteria during cross-functional site transfer planning, safeguarding product compliance.
- Owned process performance qualification by overseeing trials and supporting evidence packages.
- Eliminated variance in exhibit batches by controlling key design factors, ensuring consistency in outcomes.
- Mapped critical process parameters to quality attributes through design experiments, enhancing product integrity.
Executive
Aurobindo Pharma
Jadcherla
06.2015 - 02.2017
- Executed scale-up and validation batch runs in production, ensuring adherence to FRD documents and achieving quality standards.
- Executed batch activities according to MFR and ProTools specifications, maintaining compliance throughout production process.
- Managed development activities for tablet and capsule dosage forms, achieving optimal exposure levels for enhanced formulation effectiveness.
Education
Master of Science - Pharmaceuticals
Krishna teja pharmacy college
Tirupati, AP01-2016
Bachelor of Science - Pharmaceuticals
Bachelor of pharmacy
Rajahmundry 01-2012
Diploma of Higher Education - Biology, physics, chemistry
A. k. V. K junior college
Ongole, AP01-2006
Certificate of Higher Education - S. S. C
K. Y. G. H school
Maddipadu01-2004
Skills
- Regulatory compliance
- Injectable formulation
- Design of experiments
- Scale-up execution
- Process qualification
- Research and Development
- Technical documentation
- Data-informed decisions
- Statistical analysis
- Risk management
- Project management
- Cross-functional teamwork
- Leadership communication
- Operations management
Languages
English
Hindi
Telugu
Custom
other,other,other,other
Timeline
Executive
Torrent Research centre
06.2025 - Current
Junior Manager
MSN laboratories limited
08.2023 - 05.2025
Senior executive
Shilpa medicare Limited
04.2018 - 07.2023
Executive
Aurobindo Pharma
06.2015 - 02.2017
Master of Science - Pharmaceuticals
Krishna teja pharmacy college
Bachelor of Science - Pharmaceuticals
Bachelor of pharmacy
Diploma of Higher Education - Biology, physics, chemistry
A. k. V. K junior college
Certificate of Higher Education - S. S. C
K. Y. G. H school