08 Nov
|
Sai Life Sciences
|
Hyderabad
08 Nov
Sai Life Sciences
Hyderabad
We are looking for an experienced IT professional to manage and support GxP and Non-GxP applications across Laboratory and Manufacturing environments. The role involves administration, maintenance, validation, backup & recovery, user access management, compliance, and ensuring uninterrupted operation of critical business applications in a regulated pharmaceutical workplace.
Key Responsibilities
- End-to-end administration, maintenance, and support of GxP and Non-GxP IT systems in Laboratory and Manufacturing areas.
- Manage application and server administration activities, including installation, configuration, upgrades, and troubleshooting.
- Perform user account creation, role management, periodic access reviews, and security compliance.
- Execute backup and recovery activities using Commvault and ensure data availability.
- Support Computer System Validation (CSV) activities, including IQ/OQ/PQ documentation and change controls.
- Ensure compliance with GMP, GxP, Data Integrity, and IT Security requirements.
- Coordinate system audits, regulatory inspections, and compliance assessments.
- Manage incidents, problems, deviations, CAPAs,
and change management activities.
- Prepare and maintain SOPs, validation documents, backup reports, and system-related documentation.
- Work closely with Corporate IT teams, business users, and external vendors for issue resolution and system enhancements.
- Monitor application performance and ensure high system availability.
Desired Candidate Profile
- Bachelor's degree in Computer Science, Information Technology, Engineering, or related discipline.
- 5-9 years of experience in Pharma, API, Biotech, or regulated manufacturing environments.
- Strong knowledge of GxP applications, CSV, GMP regulations, and Data Integrity principles.
- Hands-on experience with Commvault Backup & Recovery.
- Knowledge of Windows Server administration, Active Directory, user access management, and IT infrastructure support.
- Experience in audit support, compliance documentation, and vendor coordination.
- Good troubleshooting, communication, and stakeholder management skills.
📌 Asst Manager - IT Applications & Infrastructure (GxP Systems) (Hyderabad)
🏢 Sai Life Sciences
📍 Hyderabad