Vishnu Vardhan Email & Phone Number

•Have 8 years of Experience as Design quality/ Validation engineer.•Worked as Project Manager for Pharma and holds Packaging Engineer Experience.•Extensive experience working in the Medical Device industry on Electro-Mechanical, Cardiovascular & Orthopedics Products in the capacity of Design Quality, Research and Development Engineer and Quality Engineer with emphasis on Product (Design V&V), & Process validation and verification, Risk Management and Quality Control.•Hands on experience with Track wise, SAP, Design V&V, Design Controls, TMV, Product Specifications, Traceability, CSV, Risk Benefit Analysis, Risk Management Plan and Hazard Analysis documents.•Well versed with FMEA, DFMEA, PFMEA, Gage Reproducibility and repeatability studies (Gage R&R).•Worked on Test Method Validations (TMV) to support Design Verification testing, developing, and validating test methods for in-process and final inspections and Statistical Process Controls (SPC).•Good experience in authoring and executing process and equipment validations (IQ/OQ/PQ) for assembly and packaging areas.•Skilled in implementation of 5’S, organizing Quality Circles; conducting continuous improvement projects include SIX SIGMA, KAIZEN and 5’S Extensive knowledge on providing process/quality engineering support to assess risk, address gaps in compliance and re-validate equipment and processes within the scope of remediation.•Conducted thorough due diligence assessments for potential acquisition targets, analyzing financial, operational, and regulatory aspects to evaluate risks and opportunities.•Hands on experience and solid understanding of complex manufacturing processes, addressing issues related to Process development, Corrective Actions Preventive Actions (CAPAs), Nonconformance Material Reports (NCMRs) and performing Root Cause Analysis (RCA).•Led cross-functional teams in the configuration and optimization of CTMS platform to meet study-specific requirements.•Implemented Veeva Vault solutions to streamline regulatory compliance and ensure adherence to FDA and ISO 13485 requirements.•Good working knowledge of MINITAB, Design Requirements/ Flow down and Cognition Cockpit.•In-depth understanding of the regulations related to ISO 13485, ISO 14971, 21 CFR 820.•Extensively used Fault Tree Analysis, 5-Why and Why-Why methodologies.•Successfully executed Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).•Solid knowledge of quality tools such as capability studies, Normality test, design of experiment, Control Plans, PPAP & GD&T.

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  Tamil Nadu Dr. M.G.R. Medical University (Tnmgrmu)

  Bachelor Of Pharmacy - Bpharm