QA Auditor

IQVIA•Durham, NC

About The Position

Provide global regulatory oversight of validation management as part of the Quality Management System. This oversight includes developing IQVIA Laboratories policy and procedure related to GxP compliance, guidance, audit support, review of validation deliverables, and approving release for use as related to Laboratory System Validations.

Requirements

Bachelor’s Degree
3+ years of Quality Assurance experience
Experience with QLIMS, ULTRA, Chromeleon, Spectrophotometer, Top CAT, and ABI Sequencers
GXP experience
Or equivalent combination of education, training and experience.
Experience Hosting Client or 3rd Party On-Site Audits and Conducting Internal Audits of various Clinical Trial Quality Sub Systems, including managing organizational responses to client or 3rd party audit reports.
Experience working in auditing and compliance of Computer Systems within an FDA regulated environment, such as Clinical Trials, or within a SaaS provider whose products target FDA regulated companies and whose products must be able to be validated to be compliant with 21CFR Part 11.
Expert knowledge of Computer Systems Validation (CSV) in a life science or regulated environment required.
Experience with software validation and testing methodologies, documentation and product specifications in an FDA regulated environment such as pharmaceutical, biotech or medical device required.
Knowledgeable in the following regulations/regulatory guidelines: 21 CFR Part 11, Electronic Records – Electronic Signatures; General Principles of Software Validation - Final Guidance for Industry and FDA Staff; Good Automated Manufacturing Practices (GAMP) guidelines; or other methodologies for Computer Systems Validation in a regulated environment and Data Integrity requirements.
Comprehends GxP computerized systems documentation such as validation plans, requirements and specifications, risk and gap assessments, test plans, qualification protocols, phase reports and summary reports.
Skilled at PowerPoint, Excel, Project Management and other similar tools. Experience with SharePoint and Smartsolve is a plus.
Effective organization, communication, and team orientation skills.
Ability to manage multiple ongoing projects and deadlines.
Excellent written and oral communication skills.
Strong level of detail, problem solving, and organizational skills.
Strong training capabilities.
Ability to initiate assigned tasks and to work independently.

Responsibilities

Plan, schedule, conduct, report, and close Clinical Trial Laboratory Technology Systems Audit activities in IQVIA globally, or its affiliates, to assess compliance with applicable GXP regulations/ GAMP (Good Automated Manufacturing Practices) guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions. Thorough auditing evaluates the proper implementation of Software Development Lifecycle (SDLC) methods as they relate to Computer Systems Validation (CSV), IT Quality Systems, and Technology in general.
Evaluate audit findings and prepare and distribute reports to operations staff and management and ensure associated corrective/preventive actions (CAPA) are followed up on and implemented.
Manage/oversee quality events updates in the electronic quality management system (eQMS) and/or maintain the eQMS and provide support in relation to the audit lifecycle.
Perform independent compliance review of pre-validation deliverables and post-validation documentation
Manage Quality Issues. Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closures for quality events arising from Quality Issues, Audits, Inspections or during similar QA activities.
Keep current with regulatory developments, including GxP, 21 CFR Part-11, EU Annex 11, GAMP, ICH, risk management, corporate policies and procedures, etc. to ensure IQVIA meets or exceeds industry’s best practices for compliance and validation.
Collaborate with other IT members, QA, and business functions on validation of new systems and improvement of existing IT Quality processes/practices.
Provide consistent interpretation and implementation of regulatory controls to project teams on regulations, guidelines, compliance status, and policies and procedures.
Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
Lead/collaborate/support in QA initiatives/projects for quality, process improvements.