Principle QA Auditor

QA Auditor, Clinical Quality Assurance

APAC

ICON plc., a leading global Contract Research Organisation (NASDAQ listed) employing 13,600 people in 37 countries, seeks a highly motivated, QA Auditor  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

- More than 1 year experience in GCP QA Auditing as Auditor

- 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

QA Auditor, Clinical Quality Assurance

APAC

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 1+ 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.

Why join us?

On-going development is vital to us, and as a member of our team you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. We offer a very competitive salary and benefits package that includes an excellent retirement plan, health coverage, paid time off, income protection insurance programs, and staff recognition schemes.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.

EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin.

If you would like more information please visit our company website: www.iconplc.com  or https://careers.iconplc.com or feel free to email me directly: Jennifer.kim@iconplc.com