I am an Expert in Regulatory Compliance Solutions and a well-rounded professional with solid experience I can provide regulatory support with multiple validation life cycles to include preparation of validation plan and user requirements & functional specifications; writing and executing test scripts based on requirements & specifications; managing traceability matrices; communicating non-conformances with business liaisons; and reporting validation results. With heavy validation strength in ERP systems, particularly SAP. CURRENT PROFESSIONAL EXPERIENCE Computer Systems Validation (CSV) TECHNICAL SKILL Ø Maintain the quality systems such as Change Control, Deviation Control, Out of Specification, Out of Calibration, Control of Non-conforming products, CAPA, Product Quality Reviews, etc. Ø Handling of investigations,Events, its impactassesment and route cause analysis Ø Review of analytical reports as well as production BMRS Ø Sound knowledge in preparation of SOP’s preparation of RM & FP specification, Quality Manual, Site Master File, Validation Master Plans,protocols and Trend Analysis of API Ø Coordinating with various departments like production, R&D and outside customers /suppliers Ø Handling of quality & non-quality customer/market complaints and Handling of return and rejected goods Ø Worked as an internal auditor for various departments Ø Involved in vendor Qualification and maintaining the tracks of vendor audits Ø Qualification of analytical instruments. Ø Handled all modern sophisticated analytical instruments like HPLC,GC. ,GC-MS,LC-MS ,HPTLC,IR, and all instruments of basic quality control Key Words: CSV / Computer Systems Validation / Laboratory Systems / ERP / SAP / QC Systems / Validation / Computer Validation / Pharmaceutical / GAMP5 / GMP / Annex 11 / FDA / MHRA / Contract / Consultant