Senior Executive, Information Technology

Amneal Pharmaceuticals; Visakhapatnam District; Sur place; INR 1 000 000 - 1 600 000; Plein temps

Résumé du poste

Amneal Pharmaceuticals LLC is seeking a Senior Executive – IT to support and maintain IT systems in a regulated pharma environment in Visakhapatnam, India. The role focuses on ensuring data integrity (ALCOA+) and strict adherence to GxP, 21 CFR Part 11, and GAMP 5 lifecycle management.

The successful candidate will contribute to CSV and CSA activities, prepare validation documentation, and uphold validated state of computerized systems in a fast-paced pharmaceutical setting.

Qualifications

• Experience in a regulated pharmaceutical environment is essential.
• Knowledge of CSV/CSA activities and validation documentation.
• Familiarity with 21 CFR Part 11 requirements and electronic records.
• Ability to apply GAMP 5 principles for risk-based validation and lifecycle management.

Responsabilités

• Manage and support IT infrastructure, applications, and computerized systems in a regulated pharmaceutical environment.
• Ensure compliance with GxP requirements, data integrity principles, and applicable regulatory guidelines.
• Support CSV and CSA activities and maintain validation documentation (URS, risk assessments, validation protocols, test scripts, traceability matrices, VSR).
• 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.

Connaissances

GxP compliance

Data integrity (ALCOA+)

CSV/CSA knowledge

21 CFR Part 11

IT infrastructure management

Formation

Bachelors in IT/CS

GxP/regulatory compliance cert

Outils

Active Directory

Network security

Audit trails

Description du poste

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