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Senior Executive, IT User Support

Amneal India · Gujarat, India

Diagnostics / LaboratoryOn-siteImported listingfull-timeabout 2 hours ago

About The Role

Job Description: IT Infrastructure, End User Support & Shopfloor IT / UAM

1. IT Infrastructure & End User Support

  • Provide Level-2 technical support by diagnosing and resolving hardware, software, network, and operating system issues.

  • Administer Windows Server environments, including patch management, performance optimization, security hardening, and routine maintenance.

  • Manage Active Directory, including user accounts, Group Policy Objects (GPOs), Organizational Units (OUs), security groups, and access controls.

  • Administer Microsoft 365 services and provide end-user support.

  • Maintain LAN/WAN, Wi-Fi, switches, and endpoint connectivity.

  • Deploy and administer Mobile Device Management (MDM) solutions.

  • Perform backup, restoration, disaster recovery, and storage administration activities.

  • Monitor IT infrastructure health and coordinate with OEMs and vendors for timely issue resolution.

  • Maintain IT asset inventory, software licenses, and related documentation.

2. User Access Management (UAM) & Shopfloor IT Support

  • Manage the complete User Access Management (UAM) lifecycle, including user creation, modification, periodic access reviews, suspension, deactivation, and access reconciliation for laboratory and production shopfloor computerized systems and equipment.

  • Coordinate access approvals with Business Owners, System Owners, Quality Assurance (QA), and Human Resources (HR), ensuring complete documentation and audit evidence.

  • Ensure timely access modification and deactivation for employees who are transferred, separated, or resigned.

  • Support UAM audits, investigations, deviations, Corrective and Preventive Actions (CAPA), and change controls.

  • Ensure compliance with approved procedures, access control matrices, and applicable GxP requirements.

3. Laboratory Shopfloor IT & UAM

  • Chromatography Data Systems (CDS): Manage UAM and IT support for systems such as Empower and Chromeleon, including user provisioning, role/profile management, access reviews, and access-related troubleshooting.

  • Non-CDS Laboratory Equipment: Provide UAM and IT support for standalone and network-connected laboratory instruments and associated software, including TOC, LBPC, FTIR, Malvern, Zetasizer, and other computerized laboratory equipment.

  • Laboratory Enterprise Applications: Manage user access and provide access-related support for LIMS, QMS/Caliber, TrackWise, and other applicable GxP laboratory and quality applications.

  • Coordinate with Laboratory, Quality, Engineering, Automation, and OEM/vendor teams to resolve system access and technical issues.

  • Maintain UAM records, access approval evidence, and supporting documentation in accordance with approved SOPs.

4. Production Shopfloor IT & UAM

  • Production Control & Automation Systems: Manage and support UAM activities for SCADA, PLC, HMI, and related production equipment and application interfaces, including user provisioning, role management, access modification, deactivation, and periodic access reviews.

  • Provide IT support for electronic logbooks (eLogs) and other production shopfloor computerized applications.

  • Provide hands-on technical support during equipment and system breakdowns, coordinating with Engineering, Automation, OEM/vendor teams, and other cross-functional teams (CFTs) for timely resolution.

  • Perform and coordinate backup, restoration, and recovery activities for applicable production shopfloor computerized systems and equipment.

  • Monitor and verify time synchronization of applicable production systems and equipment against approved time sources.

  • Execute and coordinate operating system (OS) hardening, security configuration, patch management, and vulnerability remediation for production shopfloor computerized equipment, considering validated-system and GxP requirements.

  • Maintain complete documentation and audit evidence for UAM, backup and restoration, time synchronization, OS hardening, breakdown support, and other GxP IT activities.

  • Ensure continuous shopfloor IT operational readiness and support compliance with GMP, GAMP 5, 21 CFR Part 11, EU GMP Annex 11, ALCOA+, and Data Integrity requirements.

5. IT Compliance, CSV & Audit Support

  • Support internal, external, customer, and regulatory IT audits and inspections.

  • Ensure adherence to GMP, GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+, Data Integrity, and applicable cybersecurity requirements.

  • Support Computer System Validation (CSV) activities, including IQ/OQ/PQ documentation, risk assessments, and validation reports.

  • Execute IT change controls and maintain complete documentation and audit evidence.

  • Support deviation investigations, CAPA implementation, and closure, ensuring timely resolution of identified gaps.

  • Maintain continuous audit readiness across laboratory and production shopfloor IT systems.

6. Information Security & Cybersecurity

  • Support endpoint security, vulnerability assessment and remediation, and security patch management.

  • Maintain approved security configurations and ensure compliance with IT security policies.

  • Support backup integrity, restoration testing, and disaster recovery readiness.

  • Monitor and address security risks associated with laboratory and production shopfloor computerized systems.

  • Coordinate with central IT and cybersecurity teams to implement security controls without compromising validated system functionality.

7. Required Technical Skills

  • Windows Server Administration and Active Directory.

  • Microsoft 365 Administration.

  • VMware/Hyper-V Virtualization.

  • LAN/WAN, Wi-Fi, Switching, and Network Troubleshooting.

  • Mobile Device Management (MDM).

  • Backup, Restoration, Storage Administration, and Disaster Recovery.

  • User Access Management (UAM) / Identity and Access Management (IAM).

  • Laboratory and Production Shopfloor Computerized Systems.

  • ServiceNow / IT Service Management.

  • Endpoint Security, OS Hardening, Patch Management, and Vulnerability Remediation.

  • Computer System Validation (CSV), Change Management, and IT Asset Management.

8. Regulatory & Compliance Knowledge

  • Good Manufacturing Practices (GMP).

  • GAMP 5.

  • 21 CFR Part 11.

  • EU GMP Annex 11.

  • ALCOA+ principles and Data Integrity.

  • GxP computerized system compliance.

  • IT security, audit readiness, and electronic records and electronic signatures requirements.

9. Educational Qualification

Bachelor’s degree in Computer Engineering, Information Technology, Computer Science, Electronics, or a related discipline.

10. Experience

  • 5–8 years of experience in IT Infrastructure and End User Support.

  • Minimum 3 years of experience in a regulated pharmaceutical or life sciences environment.

  • Practical experience supporting laboratory and production shopfloor computerized systems in a GMP-regulated environment is preferred.

11. Behavioral Competencies

  • Strong analytical and troubleshooting skills.

  • Hands-on execution and a proactive approach to issue resolution.

  • Customer-focused mindset with a strong sense of ownership and accountability.

  • Excellent documentation, communication, and coordination skills.

  • Ability to work effectively with QA, Production, Laboratory, Engineering, Automation, and OEM/vendor teams.

  • Strong commitment to compliance, data integrity, cybersecurity, and continuous audit readiness.

Education:

  • Bachelors Degree (BA/BS) B.Tech - Required
  • Master Degree (MS/MA) M.Tech - Preferred

Experience:

  • 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

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