CSV Analyst - TAPI

Job Description

Software Validation - Validation Plan definition, URS/FS/DS, Risk Assessment, Testing Plan and Scrips, Testing Execution, PQ / User Acceptance testing guidance and support, Validation Summary Report, system WI/SOP. Validation state maintenance. Periodic Reviews of Laboratory Applications Systems with respect to compliance to SDLC, User permissions and data integrity controls. Activities and Documentation of Data Integrity controls, Back-Up/Restore processes, Disaster Recovery processes and User Management processes on Laboratory Application Systems. Understanding system requirements, discussing business process / proposals / implementation issues / data security / data integrity / compliance to application guidelines, etc. Documenting the changes and new developments as per the documentation standards. Compliance with GxP Guidelines, Good Documentation practices & activities. Your experience, qualifications & skills Background in computer science or similar IT background, or a background in chemistry or related scientific field 2-5 years of experience working with CSV within the pharmaceutical or biotech industry. Expertise in Pharma Laboratory Application Systems - User Management, BackUp/Restore processes, Data Integrity Controls as per GxP Compliance. Experience in software validations. Experience with HP gALM system & understanding of SDLC structure. Documentation related to Quality processes such as Change Controls, CAPA, Deviations and Investigations. Knowledge of GAMP5 and regulatory guidelines such as 21 CFR Part 11, EU Annex 11, etc. OS: Windows Basic knowledge of LAN / WAN Basic knowledge of Servers / Switches / Routers Strong experience with Microsoft Office application Exposure to File Server/Network Shared Drives/Shared Multifunction Devices