The Auditor 2, Quality Assurance / Technology Information Quality assists in the management of overall quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations. This includes conducting a variety of audit activities which may include, but not be limited to, internal process audits where there is a technology component, internal computerized system and equipment computerized system audits and audits of technology vendors used to support Icon.
Provides consultation, mentoring and compliance as requested on GxP areas (e.g. GCP, GLP, GMP, GPvP, GDP, etc.) focused on 21 CFR Part 11 by ensuring quality activities are performed and documented in compliance with Standard Operating Procedures (SOPs), company guidelines, and applicable regulations. Consults with Icon staff for interpretation of regulations. May have responsibility to support specific computerized system audits within the following areas: Clinical Pharmacology Unit, Bioanalytical Laboratory, Logistics, GMP Pharmacy.
Essential functions include, but are not limited to:
Performs routine and complex internal audits and vendor audits according to ICON SOPs. May function as a lead auditor on an audit team.
Plans and ensures audits are scheduled.
Conducts audits to identify non-conformities in adherence to SOPs, regulations, GCP 21 CFR Part 11 requirements, Annex 11a.
Reports non-conformities according to client or ICON SOPs and report templates.
Tracks, collects and reports responses and corrective actions per ICON SOPs.
Documents closure of audits.
Interprets regulations and guidance documents governing GxP technology supporting functions and when necessary, shares with ICON staff.
Researches published information, interacts with other QA/regulatory professionals and maintains knowledge of current expectations.
Shares questions and issues posed to QA with global ICON QA staff as necessary to ensure best advice is provided.
Compiles response from QA staff and literature and replies to internal customers and more broadly throughout Icon as needed.
Facilitates client audits of ICON to ensure auditors receive access to needed documentation and staff with minimal disruption of ongoing operations.
Provides guidance to technology and information management groups to ensure the business understands applicability of associated published regulatory guidance or regulations concerning GCP, GLP, GMP, 21 CFR Part 11, and Annex 11.
Develop and foster a positive relationship with business unit customers to ensure a common understanding, approach and appreciation for computerized systems validation (CSV).
Consult and provide risk-based recommendations for the development, testing / validation and implementation of computerized systems across the business.
Participate in the review/approval of Computer System Validation deliverables.
An undergraduate degree, or its international equivalent in STEM, health sciences, pharmacy, laboratory, clinical research, and/or auditing, etc. from an accredited institution or sufficient previous experience in auditing is required.
Approximately 5 years’ experience working within the computer system validation space within the clinical, regulatory, or quality environment within CRO/ pharmaceutical / healthcare environment.
Read, write and speak fluent English.
Excellent verbal and written communication skills, interpersonal skills.
Experience working within a clinical research organization or biopharmaceutical industry.
Experience in Quality Assurance function is required.
GxP quality assurance auditing, and GxP regulations.
Excellent organizational skills.
Knowledge of GxP, 21 CFR Part 11, Annex 11, and other regulatory requirements which impact company policies, directives, and procedures.
Good knowledge of the drug development processes, regulation awareness and scientific terminology.
Good knowledge of SOPs and related documentation in a regulated industry.
Proficiency in operating computer applications and navigating the internet.
Excellent organizational skills, be logical, systematic and curious; must be able to gather and interpret relevant information; ability to work in a high volume and strict deadline environment.
Assist with tasks associated with implementation of the audit programs.
Act as project-specific liaison and provide input for audit plans.
Must have experience presenting conclusions in a clear and concise manner.
Demonstrates ability to discern significant audit issues and propose appropriate corrective action.
Identifies problems that require additional input.
Review and assess corrective action plans according to specified timelines to assure resolution of audit findings and prevent recurrence.
Can critically analyze data.
Conducts work with minimal supervision/guidance of QA management and/or more experienced auditor.
May perform tasks with coaching from supervisor or mentor.
Ability to travel more than 20%.
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