RADHIKA MANASA KOSARAJU
Hyderabad
Summary
Dynamic Sr. Executive at GeneSys Biologics Pvt. Ltd., skilled in Computerized System Validation and regulatory compliance. Expert in test script writing and root cause analysis, driving quality improvements. Proven ability to support customer audits and enhance documentation practices, ensuring adherence to industry standards while fostering effective team collaboration.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Sr. Executive
GeneSys Biologics Pvt. Ltd
Hyderabad
06.2016 - 11.2024
- Responsible for the preparation and review of all levels of Computerised System Validation documents, including URS, VMP, and VP.
- In-depth involvement in writing and executing test scripts for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Actively supported the site during CDSCO and Customer Audits, ensuring regulatory adherence and providing technical sign-off for validation reports and events.
- Ensured implementation of Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).
- Well-versed in the preparation and review of SOPs, STPs, GTPs, and Design Review protocols.
Junior Executive
Wockhardt Biotech Park
Aurangabad
01.2015 - 06.2016
- Managed Quality Management System tasks including the identification and documentation of deviations.
- Performed systematic mapping of root causes for process deviations to identify and mitigate recurring quality trends.
- Conducted purification of Insulin and its analogues using chromatography and analyzed drug substances via HPLC.
Education
M.Tech - Biotechnology
JNTUH
Hyderabad12-2012
M.Sc - Biotechnology
Northumbria University
UK10-2011
PG Diploma - Clinical Research
NIMS
Hyderabad10-2010
B.Tech - Biotechnology
GITAM University
Visakhapatnam04-2009
Skills
- HPALM
- Test script writing
- Good laboratory practices
- Quality management systems
- Regulatory compliance
- Root cause analysis
- Deviation management
- Customer audits support
- Attention to detail
- Process optimization
- Effective communication
- Team collaboration
- Time management
- Technical documentation
- Analytical problem-solving
- Project planning
- Task prioritization
- JIRA
- Docusign
- Agilent 1200 series
Certification
Computerised System Validation (CSV) & CSA-B46, Skillbee Solution, 03/17/25
Languages
- Hindi
- Telugu, Native
- English, Advanced (C1)
Technical Skills
HPALM (Testing), JIRA (Project Management), Docusign (DMS), Agilent 1200 series, Waters Arc HPLC, Shimadzu Semi-prep HPLC/UPLC, TOC Analyzers, KF Titrator, Autotitrator (Metrom), LPLC (Akta Explorer), Spectrophotometers
Timeline
Sr. Executive
GeneSys Biologics Pvt. Ltd
06.2016 - 11.2024
Junior Executive
Wockhardt Biotech Park
01.2015 - 06.2016
M.Tech - Biotechnology
JNTUH
M.Sc - Biotechnology
Northumbria University
PG Diploma - Clinical Research
NIMS
B.Tech - Biotechnology
GITAM University