Senior Executive Information Technology

Amneal Pharmaceuticals LLC; Visakhapatnam; Sur place; INR 1 200 000 - 2 400 000; Plein temps

Résumé du poste

Amneal Pharmaceuticals LLC in Visakhapatnam seeks a Senior Executive – IT with strong exposure to regulated pharma IT environments. You will support and maintain IT systems in a validated state, ensuring compliance with GxP, data integrity (ALCOA+), and 21 CFR Part 11.

The role covers CSV/CSA activities, validation document preparation, and applying GAMP 5 principles for risk-based validation and lifecycle management of computerized systems.

Qualifications

• Experience in regulated pharma IT environments.
• Strong knowledge of GxP, data integrity (ALCOA+), and 21 CFR Part 11.
• Experience with Computerized System Validation (CSV) and CSA activities.
• Ability to prepare and maintain validation docs: URS, risk assessments, protocols, test scripts, traceability matrices, and summaries.

Responsabilités

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

21 CFR Part 11

CSV/CSA

GAMP 5

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.