Swathi Vadlamudi
Pharma QA/RA Consultant | Sterile Injectables · eQMS · CAPA · Inspection Readiness | M&A Due Diligence | FDA · EMA · MHRA | No Sponsorship Required
- Role
- Pharmacy Quality and Compliance Technician at CVS Health
- Location
- Austin, TX, US
- LinkedIn followers
- 500 followers
About Swathi Vadlamudi
I am a results-driven Quality Assurance professional with over 6 years of experience in sterile injectable pharmaceutical manufacturing, specializing in Quality Management Systems (QMS). I bring a strong commitment to regulatory compliance, data integrity, and continuous improvement, ensuring product quality and patient safety. Quality Systems Expertise: Managed Deviations, OOS, OOT, LIRs, CAPAs, and Change Controls using TrackWise Skilled in risk assessment, root cause analysis, and timely CAPA closures Hands-on experience with audit trail reviews and data integrity processes Regulatory & ICH Guidelines: In-depth knowledge of USFDA (21 CFR Parts 11, 210, 211, 820), EMA, MHRA, TGA, CDSCO, WHO Proficient in ICH Q8 (Pharmaceutical Development) Strong command of ICH Q9 (Risk Management), Q10 (Pharma Quality System), and Q13 (Continuous Manufacturing) Key Achievements: Successfully implemented robust QMS frameworks enhancing audit readiness Led cross-functional teams for complex deviation resolution Played a key role in multiple successful USFDA and global audits Core Competencies: QMS Implementation – TrackWise Regulatory Compliance (USFDA, EMA, MHRA, TGA, CDSCO, WHO) ICH Guidelines (Q8, Q9, Q10, Q13) OOS, OOT, CAPA, Deviations, LIRs Audit Readiness & Data Integrity (ALCOA+) Risk-Based Quality Systems Change Control & Documentation Review Continuous Process Improvement
Experience
Pharmacy Quality and Compliance Technician
Aug 2025 — Present · Austin, TX, US
Education
Sir C.R.R. College Of Pharmaceutical Sciences
Bachelor of Pharmacy - B.Pharm
Sir C.R.R. College Of Pharmaceutical Sciences
Master of Pharmacy - M.Pharm
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