WA
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