Mounika Pasupulati
CSV Associate
Bengaluru
Summary
I am Mounika Pasupulati, a CSV Associate at Swiss Datalynx India IT Solutions Pvt. Ltd. with over 3 years of experience in Computer System Validation (CSV). My expertise lies in validation lifecycle documentation aligned with SDLC models like V-model, Waterfall, and Agile. I specialize in GAMP guidelines, GxP compliance, 21 CFR Part 11 (USFDA), and EU Annex 11. I have independently managed complete validation life cycles of computerized systems ensuring regulatory compliance and system performance.
Overview
3
3
Languages
Work History
CSV Associate
Swiss Datalynx India IT Solutions Pvt. Ltd.
- Responsible for end to end Computer System Validation (CSV) activities, including the preparation and review of key deliverables such as the Initial Risk Assessment (IRA), Validation Plan (VP), User Requirement Specification (URS), Configuration Specification (CS), Functional Risk Assessment (FRA), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Requirement Traceability Matrix (RTM), and Validation Summary Report (VSR), ensuring alignment with GAMP 5 and regulatory guidelines (21 CFR Part 11, EU Annex 11). Actively involved in executing, and reviewing qualification protocols (IQ, OQ, PQ) to verify that systems are installed, configured, and operating as intended. Oversaw the completion of the validation life cycle by preparing the VSR and confirming system readiness for production release. Collaborated with cross-functional teams and actively participated in regular project meetings to monitor progress, resolve issues, and ensure timely execution of validation deliverables in alignment with organizational standards and regulatory compliance requirements.
Education
M.Tech -
JNTU Kakinada
01.2014
B. Tech - undefined
JNTU Kakinada
01.2011
12th - undefined
Board of Intermediate Education
01.2007
10th - undefined
Board of Secondary Education
01.2005
Skills
MS office
PERSONAL PROFILE
Name: Mounika Pasupulati Date of Birth: 1990-06-14 Address: Nyanapanahalli Main Road, Devarachikkanannahalli Bengaluru, Karnataka 560076 I confirm that the information provided in this resume is true and accurate to the best of my knowledge. Mounika Pasupulati
Timeline
CSV Associate
Swiss Datalynx India IT Solutions Pvt. Ltd.
B. Tech - undefined
JNTU Kakinada
12th - undefined
Board of Intermediate Education
10th - undefined
Board of Secondary Education
M.Tech -
JNTU Kakinada