Senior Executive, Information Technology

Amneal Pharmaceuticals LLC; Visakhapatnam; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Visakhapatnam, India, seeks a Senior Executive – IT to lead regulatory-compliant IT operations in a GxP environment. You will manage IT infrastructure, support CSV/CSA activities, and ensure 21 CFR Part 11 compliance with ALCOA+ data integrity principles.

Responsibilities include validating systems, preparing documentation (URS, risk assessments, protocols, and test scripts), and applying GAMP 5 lifecycle practices to ensure secure, auditable IT services across the

Qualifications

• Experience in regulated pharmaceutical environments with GxP awareness.
• Ability to prepare and maintain validation documentation and risk assessments.
• Familiarity with CSV/CSA activities and lifecycle validation.
• Knowledge of 21 CFR Part 11 electronic records and signatures.

Responsibilities

• Manage IT infrastructure, applications, and systems in a regulated pharma environment.
• Ensure compliance with GxP, data integrity (ALCOA+), and regulatory guidelines.
• Support Computerized System Validation (CSV) and Computer Software Assurance (CSA) activities.

Skills

GxP compliance

Data integrity

ALCOA+

GAMP 5

21 CFR Part 11

CSV

CSA

Active Directory

Email administration

Network security

Tools

URS and validation scripts

Validation protocols

Job description

We are looking for a skilled and experienced

Job Description

We are looking for a skilled and experienced Senior Executive – IT with a strong background in the pharmaceutical industry, particularly in GxP compliance, data integrity, GAMP 5, and 21 CFR Part 11. The candidate will be responsible for supporting and maintaining IT systems in a regulated pharmaceutical environment, ensuring compliance with applicable regulatory requirements, and maintaining the validated state of computerized systems.

Key Responsibilities

• Manage and support IT infrastructure, applications, and computerized systems in a regulated pharmaceutical environment.
• Ensure compliance with GxP requirements, data integrity principles (ALCOA+), and applicable regulatory guidelines.
• Support Computerized System Validation (CSV) and Computer Software Assurance (CSA) activities, as applicable.
• Prepare, review, and maintain validation documentation, including URS, risk assessments, validation protocols, test scripts, traceability matrices, and validation summary reports.
• Ensure compliance with 21 CFR Part 11, including electronic records, electronic signatures, audit trails, and access controls.
• Apply GAMP 5 principles for risk-based validation and lifecycle management of computerized systems.

Operating System and Application Administration

Backup, Restoration, and Archival

GxP System Administration and Compliance

Computer System Validation (CSV)

Active Directory and Email Administration

Network Security and Firewall Administration