Senior QA Auditor

GCP QA Auditor, Clinical Quality Assurance
China - Beijing, Shanghai, Guangzhou

ICON plc, a leading global Contract Research Organisation (NASDAQ listed) employing 13,500 people in 40 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 based in the APAC Region. A candidate ideally would have prior experience as QA auditor in clinical research, either Pharma or CRO with in depth knowledge in GCP.

Role Overview:

- 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 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%

Role Requirements:

- 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 2+ years of Quality Assurance auditing

- Detailed knowledge of GCP guidelines and relevant regulations for the conduct of clinical trials.

- Knowledge in either DM or Biostats would be a plus.

- 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.

Benefits of Working in ICON :

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.

ICON is an equal opportunity employer, including disability/veteran, and committed to providing a workplace free of discrimination and harassment.

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