Executive - IT

Job Description

Role & responsibilities: Develop and maintaining GAMP5 lifestyle documentation, including URS, FRS, Risk assessment, IQ/OQ/PQ. Completed 21 CFR Part 11 compliance assessments of laboratory systems. Developed validation master plans, IQ/OQ/PQ summary reports of computerized analytical instruments. Prepared SOPs describing validation policies and equipment operation. Configured and validated networked chromatography data systems. Responsible for identifying gaps and recommending solutions to software validation processes, procedures and practices. Perform backup activity networked based analytical instruments. To update IT security policy as per current guidelines and requirements to enhance security of all operating systems in Quality Control laboratory. Periodically review the application software and provide technical support. Administrative access of all computerized analytical laboratory instrument. User ID creation/deletion/modification, user role and access configuration and project management activities. Support and management for IT infra upcoming project. IT Infra Project execution support. IT Infrastructure/network/server management. Preferred candidate profile: Experience in a pharmaceutical industry will be an add on advantage. Experience: 3 to 8 Years Qualification: B.E. (IT) or relevant qualification related to IT.