Senior Auditor, Quality Assurance

hace 3 semanas

Buenos Aires, Argentina ICON A tiempo completo

**JOB: Senior Auditor, Quality Assurance**

**Preferred Locations: EMEA** / Mexico / Argentina**

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

**Responsibilities and Qualifications**:
Manage complex Quality Issues to include supporting Root Cause Analysis, Impact Assessment and appropriate Corrective Action and Preventive Action (CAPA) Plans. Respond to audit findings and support audit responses to assess compliance with corporate policies, industry standards, and applicable regulations.

Level 3 auditor independently conducts the following activities as assigned by Quality & Compliance (Q&C) management:

- Manage Quality Issues
- Lead Quality Issue Investigations
- Supports Operations in Root Cause Analysis and CAPA Plan preparation.
- Support Effectiveness Check development and outcomes.
- Manage CAPAs resulting from Sponsor Audits, Inspections and/ or Internal Audits.
- Assist with the implementation and maintenance of an effective Quality Management System/ Quality Assurance program within the relevant Quality & Compliance (Q&C) team.
- Perform departmental and ICON staff training regarding ICON’s quality system, Q&C tasks and processes, applicable standards, and regulations.
- Mentor new or developing Q&C staff as assigned.
- Support business development activities and Q&C initiatives as needed.
- Read, write and speak fluent English.

**What you will have**:

- 3 - 6 years’ experience working in a clinical, regulatory, pharmacovigilance, or quality environment within CRO/ pharmaceutical / healthcare industry.
- Advanced knowledge of GCP (Good Clinical Practice)
- Excellent organizational skills.
- Excellent knowledge of internal auditing standards.
- Must possess a technical knowledge that is applicable to clinical drug development.
- An undergraduate degree, its international equivalent in the sciences, technology, auditing, etc. from an accredited institution or sufficient previous experience in auditing is required
- Extensive experience in investigator site, vendor, and process audits.
- Must be willing to travel up to 35%
- Excellent knowledge of MS Office (including Microsoft Word, PowerPoint and Excel).
- Experience working in a quality assurance role within an internal audit function (preferred).
- Critical thinker that sees the "big picture" (e.g. overall themes, trends, goals), generates innovative ideas and solutions to problems and makes recommendations in the face of complexity, conflicting pressures and ambiguous circumstances.
- Professional communicator, able to gain and maintain a trusted relationship while delivering difficult messages
- Team worker, able to listen to others but also influence in order to see the wider picture and achieve a vision

**Benefits of Working in ICON**:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best-in-class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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