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QA Auditor II

ICON plc, a leading global Contract Research Organisation (NASDAQ listed) employing 13,100 people in 38 countries, seeks a highly motivated, QA Auditor II to join its global QA Audit team to preform audits of clinical trial data and records in order to assure compliance with ICON’s SOP’s, Good Clinical Practice guidelines, relevant regulations and ISO 9000 requirements.

We are seeking a QA Auditor who is Native in Japanese / Chinese and can speak English at business level.

Must have a minimum of 2 years' auditing experience. Candidates with experience from a regulatory authority would be a plus.

The Role:

Effectively plan and conduct regular and random internal and external, QA Audits in order to assure that clinical studies managed by ICON are of the highest standard and are in compliance with the requirements of ICON or Sponsor SOP’s, study protocols, relevant regulations and guidelines and with ISO 9000 requirements.
Preform quality system audits if required.
Preform contract audits for Sponsor companies are required.
Ensure that audit results are formally recorded and reported and that corrective/ preventative actions are documented.
When appointed lead auditor, perform the duties assigned in an efficient and effective manner. This includes liaison with the project manager on all QA issues, including audit planning and review of audit results.
Assist with the development of the project audit procedures.
Assist in training new QA auditors.
Assist in training ICON staff regarding GCP, ISO 9000, role of QA, regulatory inspections etc.
Conduct induction/ orientation of new staff in ICON quality policies and procedures.
Assist with business development activities (such as marketing presentations) when appropriate.
Provide a benchmark of auditing competencies to inexperienced colleagues.
Assume additional QA responsibilities as directed by QA manager.
Keep the person whom the QA auditor reports to informed of any QA issues within the department that require attention.
Travel is approximately 35%

Specifications:

Bachelor’s Degree or local equivalent in medicine or science.
Background in medicine, science and/ or other relevant discipline and appropriate experience.
Previous experience in Quality Assurance auditing and/or 2-3 years of proven clinical research experience.
Detailed knowledge of GCP guidelines and relevant regulations for the conduct of clinical trials.
Ability to review and evaluate clinical data/ records.
Excellent communication and interpersonal skills.
Ability to successfully implement quality plans for specific phases of a trial.
Ability to liaise with project teams.
Good understanding of drug development and clinical trial process.

Benefits of Working in ICON

ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career.

We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

A better career. A better world. A better you.

Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader.
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QA Auditor II

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