Senior Executive IT User Support

Amneal Pharmaceuticals; India; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking an experienced IT Infrastructure and End User Support professional in India. The role focuses on L2 support for hardware, software, network, and OS issues, plus managing UAM for laboratory and production shopfloor systems.

Responsibilities include AD/M365 administration, patching, OS hardening, CSV support, and coordinating with QA, HR, and OEM/vendor teams to ensure compliant access controls and audit readiness.

Qualifications

• Bachelor’s degree in Computer Engineering, Information Technology, Computer Science, Electronics, or a related discipline.
• 5–8 years of IT Infrastructure and End User Support experience.
• Minimum 3 years of experience in a regulated pharmaceutical or life sciences environment.
• Experience with GMP/GxP compliance in lab and shopfloor IT environments is preferred.

Responsibilities

• Provide Level-2 IT infrastructure and End User Support.
• Administer Windows Server, AD, M365, and virtualization.
• Manage UAM lifecycle for lab and production shopfloor systems.
• Support GMP & regulatory IT audits and CSV activities.
• Coordinate with QA, HR, and system owners for access approvals.

Skills

Windows Server

Active Directory

Microsoft 365

VMware/Hyper-V

Networking

MDM

Backup & DR

UAM/IAM

GxP IT Compliance

USer ServiceNow

Education

Bachelor’s degree in Computer Engineering/Information Technology/Computer Science/Electronics

Master’s degree (preferred)

Tools

ServiceNow

LIMS/QMS/Caliber/TrackWise

Job description

Job Description:

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.

Qualifications

Education:

• Bachelors Degree (BA/BS) B.Tech - Required

• Master Degree (MS/MA) M.Tech - Preferred

• 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses: Requirements: