Rajasekhar kuruvagantela
Deputy manager (AQA)
Summary
Dynamic professional with over 15 years of experience in the pharmaceutical industry, specializing in laboratory quality assurance in quality control for OSD products. Proven track record of enhancing product quality through effective laboratory management and strict adherence to regulatory standards, ensuring compliance and excellence. Expertise in leading investigations into out-of-specification (OOS) results and implementing corrective and preventive actions (CAPA), driving collaboration among cross-functional teams and spearheading continuous improvement initiatives. Proficient in Laboratory Information Management Systems (LIMS), optimizing analytical testing processes to achieve operational excellence and streamline workflow efficiencies.
Overview
15
15
years of professional experience
3
3
Languages
Work History
QA Deputy Manager ( AQA)
Zydus Cadila Healthcare Ltd.
04.2018 - 12.2025
- As a Analytical Data Reviewer Deputy Manager in Zydus Cadila Healthcare Ltd, Ahmadabad. Since March 2018 to till date.
- Conduct the self-inspection audit of the department as per the schedule and to ensure and review the compliance of observation during self-inspection.
- Review and approval of analytical documents such as raw material,in process, finished product and Stability samples.
- Ensures adherence to cGMP/regulatory and internal SOP requirements.
- Review of analytical data for accuracy,completeness and data included lab notebooks, chromatography,and electronic data/audit trails.
- Performed training with analysts on proper documentation,GMP compliance.
- Handling of OOS/OOT including procedure for reporting, investigation, review, approval and closure of QMS
- Conducts laboratory investigation on OOS/OOT results. Conducts monthly internal Audits of various departments within the organization to regulatory requirements.
- Monitored current FDA regulations as related to laboratory functions and compliance
- Ensure the implementation of GLP and GDP in the laboratory.
- Promoted a positive work culture.
QC Associate
DR.Reddys Pharma Ltd.
02.2016 - 02.2018
- Conducted analysis of physical parameters and chemical tests on samples as directed by seniors.
- Performed instrument analyses including Assay,RS Dissolution tests, and UV spectrophotometry.
- Documented results and completed calculation sheets for all analyses.
- Tested in-process and finished product batches for assay, residual solvent, dissolution, and water content.
- Monitored FDA regulations to ensure laboratory compliance and operational integrity.
- Ensured implementation of Good Laboratory Practice (GLP) and Good Documentation Practice (GDP).
- Assisted in the continuous improvement of quality control systems through regular audits, feedback, and process updates.
- Enhanced laboratory safety with the implementation of proper protocols and regular equipment maintenance.
- Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
QC Executive
Kem well Bio- Pharmaceutical Ltd.
03.2014 - 02.2016
- Analysis of all physical parameters and chemical test of In-process sample and finish product sample.
- Performing Analysis of cleaning verification sample and Dissolution.
- Maintained laboratory ethics and ensured data integrity during documentation, and collaborated with senior staff to investigate laboratory incidents and Out of Specification (OOS) results.
- Ensure the implementation of GLP and GDP in the laboratory.
QC Chemist
Hetero Labs Ltd.
06.2011 - 03.2014
- 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 Officer
Jupiter Bio-Science. Ltd.
10.2010 - 06.2011
- Conducted in-depth analysis of Raw Materials and shared the requirements with the concerned teams accordingly.
Education
MSC - Organic Chemistry
B.Sc - Chemistry
Intermediate - Bi.P.C
S.S.C -
Skills
Laboratory ethics
Personal Information
Date of birth: 12/07/87
Permanent address: S/o seshaiah
Mundlapadu(vil)
Giddalur(mandal)
Prakasam(Dist)
Andhra pradesh.
Education
Distinction,Metric
Timeline
QA Deputy Manager ( AQA) - Zydus Cadila Healthcare Ltd.
04.2018 - 12.2025
QC Associate - DR.Reddys Pharma Ltd.
02.2016 - 02.2018
QC Executive - Kem well Bio- Pharmaceutical Ltd.
03.2014 - 02.2016
QC Chemist - Hetero Labs Ltd.
06.2011 - 03.2014
QC Officer - Jupiter Bio-Science. Ltd.
10.2010 - 06.2011
Acharya Nagarjuna University - B.Sc, Chemistry
board of Intermediate - Intermediate, Bi.P.C
Secondary School Education - S.S.C,
Acharya Nagarjuna University - MSC, Organic Chemistry