Swathi Gajula
#ITCSV #CSV #Complince #GAMP5 #CFR #AUDIT #LIFE SCIENCES #RISKASSESSMENT #Qualification #IQ #OQ #DataMigration
- Role
- Senior Consultant at EY
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Swathi Gajula
In the life sciences world, every system validated, every process improved, and every…
Experience
Senior Consultant
Jan 2024 — Present · Hyderabad, IN
Lead end-to-end Computer System Validation (CSV) projects ensuring compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11Act as Primary Point of Contact for validation, coordinating with global cross-functional teamsOversee validation documentation, change control, and risk assessmentsImplement process optimization strategies to improve validation efficiency and audit readinessManage HP ALM for defect tracking and PQ execution supportCollaborate with HR and leadership teams for recruitment, onboarding, and team development
Education
Vidya Vani High School
Secondary School of Education
1989 — 2002
Skills
- U.s. Food and Drug Administration (Fda)
- Documentation
- Medical Devices
- Analytical Chemistry
- Managed Care
- R&D
- Regulatory Affairs
- Lifesciences
- Gmp
- Validation
- Employee Training
- Lc-Ms
- Life Sciences
- Hplc
- Computerized System Validation (Csv)
- Standard Operating Procedure (Sop)
- Pharmaceutical Industry
- Fda
- Quality Assurance
- Document Review
- Gcp
- Data Analysis
- Equipment Qualification
- Chemistry
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