IT QA Analyst

4 days ago

Durham, NC, United States Aurobindo Pharma USA Full time

Division Overview

Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has give Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.

Job Overview

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.

Responsibilities

  • Develop and execute CSV protocols (IQ, OQ, PQ) for GxP systems.
  • Prepare Validation Plans, Risk Assessments, and Traceability Matrices.
  • Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity principles.
  • Review and approve system specifications, configuration documents, and SOPs.
  • Perform periodic reviews and maintain validated state of systems.
  • Collaborate with IT, QA, and business teams during system implementation and upgrades.
  • Manage change control for validated systems.
  • Support audit readiness and respond to regulatory inspections.
  • Train stakeholders on CSV requirements and best practices.
  • Participate in risk assessments and impact analysis for system changes.
  • Support validation activities including IQ/OQ/PQ for IT systems.
  • Maintain QA documentation in accordance with SOPs and regulatory guidelines.
  • Provide training and guidance on QA best practices to IT and business teams.
Qualifications - Skills & Requirements
  • Bachelor's degree in Computer Science, Information Technology, Engineering, or Life Sciences.
  • 3-5 years of experience in CSV within a regulated environment (pharma, biotech, medical devices).
  • Strong knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11.
  • Experience with ERP, LIMS, CDS, MES, and other GxP systems.
  • Excellent documentation and communication skills.
  • Familiarity with risk-based validation approaches.
Education & Experience
  • Bachelor's Degree in Computer Science

Physical Requirements

OFFICE POSITION - While performing the duties of this job the employee is required to: • Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment • Specific vision abilities required by this job include close vision requirements due to computer work • Light to moderate lifting is required • Moderate noise (i.e. business office with computers, phone, and printers, light traffic). • Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
Additional Physical Requirements

No Additional Requirements

Blood/Fluid Exposure Risk

Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.

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