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
Strong ability to manage multiple projects, tasks, and goals within deadlines
Smart working
Ability to work independently as well as in team
Sincere at work and feel responsible
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