QA IT Analyst

Aurobindo Pharma USA, Inc.•Durham, NC

3d•Onsite

About The Position

The IT QA Analyst is responsible for ensuring that computerized systems used in GxP-regulated environments are validated and maintained in compliance with regulatory requirements, industry standards, and company policies. This role involves planning, executing, and documenting validation activities for IT systems, laboratory instruments, and manufacturing equipment.

Requirements

Proven expertise in reviewing and approving validation deliverables for key quality and laboratory systems such as LIMS, QAMS, Waters Empower, DMS, and Training Management Systems.
Well-versed in SDLC processes including Change Control, Release Management, and Deviation handling for validated systems.
Competent in test script and defect review/approval for system validation and ongoing compliance.
Adept in supporting internal and external audits, inspections, and data integrity governance activities.
Hands-on experience managing user account setup, system configuration, and access control for QA IT systems.
Minimum 4-5 Years of Experience in CSV and IT QA software validation (QMS, PLC).
Strong knowledge of working with FDA 21 CFR Part 11 Compliance, GxP systems GAMP 5 and EU Annex 11.

Responsibilities

Ensure key software development lifecycle (SDLC) processes, such as Change Control, Release, Deviations, etc.
Review and approval of test scripts and defects associated with computer systems validation.
Partner with IT to ensure risk assessments, incident management, and Oversight is aligned with corporate and data protection standards.
Support internal and external regulatory inspection activities related to validated systems.
Provide support to Quality Programs such as Data Integrity Governance, Investigations, training, and others on the assigned computerized systems.
Ability to manage multiple projects, create and work within timelines, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team.
Operate effectively and with minimal supervision, within a team or independently, performing special projects and duties as assigned.
Follow the laid down Quality Culture Principles and Behaviors
QA IT Personnel will act as Admin to the Creation of user accounts, and Configure Settings and providing permission to the user in different software for Quality.
system, for example: - DMS, QAMS, Nichelon, etc., but not limited to the mentioned.