Triveni Gopisetti
Goteru
Summary
Experienced QA professional with strong knowledge of GMP and ISO 17025:2017 standards. Skilled in internal audits, document review, e-QMS handling, and method validation as per ICH guidelines. Proven ability to support regulatory audits, ensure compliance, and train junior staff effectively.
Overview
10
10
years of professional experience
1
1
Language
Work History
Sr. Quality Auditor
Vimta labs Pvt Limited
06.2022 - Current
- Conduct internal audits to ensure compliance with GMP and ISO 17025:2017 standards.
- Prepare and review quality documents such as SOPs, protocols, reports, and calibration certificates.
- Review batch analysis, raw data, and Certificates of Analysis (COAs) through LIMS.
- Review instrument-related records including revalidation, logbooks, and calibration data.
- Evaluate instrument data and audit trails for AAS, PXRD, DSC, TGA, PSA, and their respective software systems.
- Verify logbooks, temperature & humidity records, and calibration records on time.
- Manage all e-QMS events including change controls, deviations, incidents, and CAPAs.
- Review activities related to method validation, verification, and transfer in line with guidelines.
- Support Computer System Validation (CSV) and Good Manufacturing Practice (GMP) initiatives.
- Ensure HVAC/AHU systems comply with GMP requirements.
- Participate in the execution of the Business Continuity Plan (BCP) and prepare detailed reports to support operational resilience and risk mitigation.
- Provide training and guidance to junior staff on quality systems and regulatory requirements.
- Collaborate with cross-functional teams to resolve audit findings and implement corrective actions.
- Support and participate in regulatory and customer audits.
- Ensure overall compliance with SOPs and regulatory standards.
Junior Executive in R&D Synthesis
LAVYBENS PHARMACEUTICALS PVT.LTD
11.2015 - 04.2018
- Hands-on experience in synthesis and research & development activities.
- Skilled in performing a wide range of chemical reactions including: Oxidation, Reduction, Bromination, Esterification, Cyanidation, Cyclisation, Halogenation, Methylation, Nitration, Condensation, Hydrogenation, Alkylation, Acylation, and Reductive Amination.
- Well-versed in purification techniques such as: Recrystallisation and Column Chromatography.
- Proficient in executing chemical synthesis from milligram to gram scale across various reaction types.
Education
Master of science - Analytical chemistry
MVR Degree and PG college
01.2022
Bachelor of science - M.P.C
S.K.S.D MahilaKalasala
01.2013
Skills
Good analytical and decision-making
Interests
Reading books, listening music, Dancing, Playing shuttle
Disclaimer
I hereby declare that all the details mentioned in this resume are correct and true to the best of my knowledge. I take full responsibility for the authenticity of the information. Place: Hyderabad (Triveni Gopisetti)
Timeline
Sr. Quality Auditor
Vimta labs Pvt Limited
06.2022 - Current
Junior Executive in R&D Synthesis
LAVYBENS PHARMACEUTICALS PVT.LTD
11.2015 - 04.2018
Bachelor of science - M.P.C
S.K.S.D MahilaKalasala
Master of science - Analytical chemistry
MVR Degree and PG college