Executive - IT

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.