Summary of Qualifications * Provide validation services for pharmaceutical clients to be compliant with FDA regulations utilizing CSV methodology * Professional with a strong background in validation, quality, information technology, and chemistry domains for pharmaceutical and medical device industry * Proven knowledge of FDA regulatory requirements, including cGxP, GLP, GMP, Sarbanes-Oxley (SOX), 21 CFR 210/211, 21 CFR 58, 21 CFR Part 11, 21 CFR Part 820 and GAMP * Possess excellent computer system validation, regulatory compliance, SOP development, auditing, and laboratory skills * Develop of a variety of regulatory deliverables, including project plan, project schedule, validation plans, protocols, test scripts, training materials, reports, risk analysis, audit documents, periodic review, data migration plans, and procedures * Lead validation projects, provide schedule, progress and status reports conduct trainings * Extensive experience with validation of IT platforms and computerized systems such as Documentum, ComplianceWire LMS, PeopleSoft, Clinical Trails, PQMS, EtQ, TrackWise Quality Management, CAPAs, SAP, inventory tracking and systems related to drug development, pre-clinical studies and medical devices * Extensive experience with qualification and validation of laboratory systems and equipment such as Empower, LabWare, AKTAs, HPLCs, GCs, AAs, FTIRs, UV/VIS, PCRs, LIMS, HMI, PLC.

Highlights:

• Services
• Data Migration
• Legacy
• Quality Assurance
• Assessments
• Audit
• Management
• Quality Management
• Pharmaceutical
• Quality
• validation
• CSV
• business analyst