Sivakanth Medesetty
Vijayawada
Summary
Assistant Manager with extensive experience in the review and planning of raw materials, packaging materials, stability testing, Quality and regulatory compliance at Amneal Pharmaceuticals.uticals. Demonstrated analytical skills and expertise in method validation resulted in successful investigations and timely corrective actions. Proficient in technical report writing and fostering cross-team collaboration to enhance product quality and integrity.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Assistant Manager-Analytical Quality Assurance
Amneal Pharmaceuticals Private Limited (Oncology)
Hyderabad
06.2024 - Current
- Review of Analytical data of Raw Material, Finished product and Stability samples.
- Releasing of Raw Material, Packaging Material, Working Standard Qualification, Calibration and Finished Products in LIMS software.
- Review and approval of Laboratory incidents, OOS and OOT investigations and monitoring of the analysis and lab activities.
- Preparation of Laboratory incidents, Deviations, OOT and OOS trends quarterly.
- Review of OQ, PQ, IQ data as part of instrument qualification in Quality Control Laboratory.
- Review of Quality Risk assessments in Quality Control Laboratory. Working standards qualification data review and approval.
- Working standards qualification data review and approval.
- Review of Raw Material and Finished product COA’s.
- Key member in internal audits as an Internal Quality auditor and conducting self- inspections.
- Active participation as a team member for on-site audits (FDA and third-party audits).
- Stability chambers temperature-monitoring review on daily basis.
- Review and approval of Method validation protocols and reports
- Review of commercial stability protocols and Exhibit batches stability protocols.
- Review of Standard test procedures and specifications of Raw Material, in process and finished product.
- Monitoring of CAPA effectiveness on Quarterly basis.
- Review of change controls of Quality control laboratory.
- Review the standalone and Chromatographic system like Chromeleon and Empower audit trail reports on monthly basis.
- Review the Calibration data of HPLC, GC, IC, UV, IR, KF titrator, pH, Conductivity meter, Analytical Balances and TOC.
- Review of Water analysis data on daily basis.
- Review of Water trend analysis data on Quarterly basis.
- Compilation of stability trend data for RA submission.
- Adheres to the timelines of the assigned SOP’s and Quality system manuals.
- Verification of Instrument logbooks, temperature-monitoring records on daily basis.
- Interaction with cross-functional teams based on the product investigations and project requirements.
- Supporting for Analytical Research and Development activities like Risk Assessments, Method Verification and Method Transfer.
Senior Executive-Quality Control
Amneal Pharmaceuticals Private Limited (Oncology)
Hyderabad
04.2017 - 05.2024
- Oversaw daily review of analytical documents to maintain quality standards.
- Coordinated comprehensive stability testing for various product batches, ensuring accurate data management.
- Monitored stability of products, raw materials, and samples to comply with shelf-life requirements.
- Collaborated with research and regulatory teams to evaluate stability data for potential formulation changes.
- Prepared stability study protocols and reports, facilitating regulatory submission processes.
- Executed investigations and root cause analyses for OOS results, ensuring timely corrective measures.
- Ensured compliance with GMP, SOPs through diligent record maintenance of QC testing activities.
- Managed stability chamber operations while reviewing method validation protocols systematically.
Executive-Quality Control
Hospira Healthcare (Injectable & OSD)
Chennai
01.2015 - 04.2017
- Conducted analysis of raw and packaging materials to ensure compliance with quality standards.
- Reviewed analytical documents for raw and packaging materials, identifying discrepancies.
- Analyzed finished and in-process samples to maintain product integrity.
- Prepared laboratory investigations for out-of-specification, out-of-trend, and incident reports.
Education
M.Pharmacy - Pharmaceutics
Dr. MGR Medical University
Chennai01.2014
B.Pharmacy -
Dr. MGR Medical University
Chennai01.2011
Skills
- Analytical skills
- Communication skills
- Experimental design
- Technical report writing
- Laboratory instrument proficiency
- Regulatory compliance knowledge
- Stability testing
- Quality control processes
- Method validation
- Root cause analysis
- Investigative analysis techniques
- Computer proficiency
Analytical Instruments Handled
High-performance liquid chromatograph (HPLC): Waters, Shimadzu, and Agilent
ICP-MS: Thermo.
Gas Chromatography (GC): Agilent and Perkin Elmer Clarus 580.
Ion Chromatography: Thermo Dionex-5000.
UV-Visible Spectrophotometer: Shimadzu.
Dissolution Apparatus: Electrolab.
Disintegration Apparatus: Electrolab.
KF Titration: Metrohm.
Atomic Absorption Spectrophotometer: Thermo.
IR Spectrophotometer: Shimadzu.
Software's Handled
- Laboratory Information Management System (LIMS), Chromeleon software version 6.8, Empower-3, UV Probe, IR Solutions
- Chromeleon software version 6.8, Empower 3, UV Probe, IR Solutions
- Empower-3
- UV Probe
- IR Solutions
- Tiamo
Languages
Telugu
First Language
Hindi
Advanced (C1)
C1
English
Advanced (C1)
C1
Certification
- DR No: 67-8-14, NSM School Road, Patamata, Vijayawada, 520010, Krishna Dist, Andhra Pradesh.
Disclaimer
I hereby declare that the above information is correct to my knowledge and any false was noticed at any instance of time I do bound for the action taken by you.
Timeline
Assistant Manager-Analytical Quality Assurance
Amneal Pharmaceuticals Private Limited (Oncology)
06.2024 - Current
Senior Executive-Quality Control
Amneal Pharmaceuticals Private Limited (Oncology)
04.2017 - 05.2024
Executive-Quality Control
Hospira Healthcare (Injectable & OSD)
01.2015 - 04.2017
M.Pharmacy - Pharmaceutics
Dr. MGR Medical University
B.Pharmacy -
Dr. MGR Medical University
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