Rajasekhar Kuruvagantela
Ahmedabad
Summary
Dynamic professional with over 15 years of experience in Lab Quality Assurance within the pharmaceutical industry, specializing in regulatory compliance for OSD and parenteral formulations. Proven track record in ensuring adherence to regulatory standards while enhancing product quality through effective laboratory management and cross-functional collaboration. Expertise includes leading investigations into out-of-specification (OOS) results, implementing corrective and preventive actions (CAPA), and optimizing analytical testing processes through LIMS management. Committed to leveraging cutting-edge technologies to drive innovative decision-making and contribute to an organization that prioritizes professional development and continuous growth.
Overview
16
16
years of professional experience
Work History
Deputy Manager
Zydus Cadila Healthcare Ltd
Ahmedabad, India
03.2018 - Current
- Executed thorough evaluations of laboratory data to support product release and maintain quality assurance standards.
- Oversaw the review process of analytical data to ensure accuracy and completeness. Managed the integration of data from lab notebooks, chromatography, and electronic data/audit trails.
- Conducted comprehensive training for analysts to ensure adherence to documentation and GMP compliance protocols.
- Performed detailed analysis of oos/oot results to identify root causes and implement corrective actions.
- Analyzed departmental operations through monthly audits to verify alignment with established regulatory requirements.
- Oversaw monitoring of current FDA regulations to ensure laboratory compliance and operational integrity.
- Facilitated adherence to GLP and GDP standards to enhance laboratory compliance and operational efficiency.
- Cultivated an inclusive and supportive work environment to enhance employee morale and collaboration.
QC Associate
DR.Reddys Laboratories Ltd
Hyderabad
02.2016 - 02.2018
- Performed detailed evaluations of physical and chemical properties of in-process and finished product samples to ensure quality standards are met.
- Executed instrument analysis, including friability, dissolution tests, and UV spectrophotometry, ensuring accurate documentation and completion of calculation sheets.
- Executed testing protocols for in-process and finished product batches, including assay, dissolution, and water content analysis.
QC Executive
kemwell Biopharma Pvt Ltd
Bangalore
03.2014 - 02.2016
- Conducted analysis of physical parameters and chemical tests for in-process and finished product samples.
- Assisted in analyzing cleaning verification and dissolution samples.
- Maintained laboratory ethics and supported documentation integrity while collaborating with senior staff to resolve laboratory incidents and out of specification results.
- Applied good laboratory practices and good documentation practices in the laboratory.
QC Chemist
Hetero Labs Ltd
Baddi
06.2011 - 02.2014
- Conducted product release analysis for exhibit and innovator samples, ensuring compliance with standards.
- Performed method transfer analysis and analytical method validation of pharmaceutical products.
- Executed stability analysis to assess product viability over time.
QC Tr.Chemist
Jupiter Bio sciences
Hyderabad
10.2010 - 06.2011
- Conducted in-depth analysis of Raw Materials and shared the requirements with the concerned teams accordingly.
Education
Master of Science - Organic Chemistry
Acharya Nagarjuna University
Guntur, India01-2010
Bachelor of Science - Chemistry
Acharya Nagarjuna University
Giddalur, India01-2008
High School Diploma -
Board of Intermediate
Giddalur, India01-2005
Secondary School Education
Mundlapadu 01-2003
Skills
- Laboratory ethics
- Process optimization
- Equipment maintenance
- Inventory management
- Training and development programs
- Documentation practices
- Strategic decision-making Resource optimization Time management Team building
- High Performance liquid chromatography (Waters, Shimadzu, Agilent)
Instrument Handled:
- Expertise in liquid chromatography techniques
- Proficient in UV/VIS analysis techniques
- Experience with dissolution testing equipment
- Proficient in Shimadzu FT-IR analysis
- Experience with moisture analysis using Karl Fischer
- PH meter (Mettled Toledo)
- Friability Test Apparatus (Electro Lab)
- Disintegration Test (Electro Lab)
Professional Attributes
I consider myself to be confident and a strong participant in group ventures. I enjoy working as a team, but can easily work on my own initiative. I look forward to new opportunities and new challenges and look forward to being associated and growing in such an organization.
Timeline
Deputy Manager
Zydus Cadila Healthcare Ltd
03.2018 - Current
QC Associate
DR.Reddys Laboratories Ltd
02.2016 - 02.2018
QC Executive
kemwell Biopharma Pvt Ltd
03.2014 - 02.2016
QC Chemist
Hetero Labs Ltd
06.2011 - 02.2014
QC Tr.Chemist
Jupiter Bio sciences
10.2010 - 06.2011
Master of Science - Organic Chemistry
Acharya Nagarjuna University
Bachelor of Science - Chemistry
Acharya Nagarjuna University
High School Diploma -
Board of Intermediate
Secondary School Education