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Video meeting . 10 mins
100
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Video meeting . 30 mins
600

About me

1. CSV/CSA professional experience in validation, and testing of the various applications in Life Sciences, Manufacturing, and Medical Devices Domains. 2. Expertise in managing, controlling, and implementing End to End Software Testing/Validation Life Cycle in compliance with client-defined Quality Management System 3. Possess practical experience working on Project Management including Quality Delivery Management, Stakeholder Management, Scope Management, Change Management, Risk Management, and Metrics-Based Management, with involvement in all phases of validation/testing life cycle for products developed for large pharmaceutical customers in the life sciences industry. 4. Expertise in Computer System Validation and proficient knowledge in CSV, CSA, GxP, GAMP 5, FDA Regulations, 21 CFR Part 11, Data Integrity, Part 820 QSR, ISO 13485, ISO 9001:2015, MHRA, EU GMP Annex 11, GDPR Compliances, ICH Q9 and ISPE framework on Quality Risk Management 5. Expertise in validating and testing various systems and products like TrackWise, Veeva vault, ARISG, Documentum for Life Science Solution Suite (D2-LSQM), and SAP (ECC 6.0).