QA IT Analyst

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

• 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.
  
  

Qualifications - Skills & 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.
  
  

Education & Experience

• Bachelors Degree
  
  

Compensation

Min

USD $25.00/Hr.

Max

USD $45.00/Hr.

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.,

• 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.
  
  

,

• 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.