The opportunity
Validation of a new global ELN system for the R&D organization. It is starting from building the system and implementation in all the R&D sites. Once implemented completely, then to manage the system validation maintenance and change management of further enhancements. Support with some additional CSV activities for TAPI sites.
How you’ll spend your day
- 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 field2-5 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 : WindowsBasic knowledge of LAN / WANBasic knowledge of Servers / Switches / RoutersStrong experience with Microsoft Office applicationExposure to File Server / Network Shared Drives / Shared Multifunction DevicesMake a difference with Teva Pharmaceuticals