Specialist, QA Auditor

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QA Auditor Quality Assurance

About the job

We are looking for a Clinical Laboratory/ Good Clinical Practice (GCP) QA Auditor to join us! Have you previously worked in roles supporting biomarker operations or clinical laboratories or supporting Clinical Trials such as a Clinical Research Associate Clinical Trial Manager GCP Quality Management/ Compliance Have you got some knowledge of GCP/ GcLP or are you someone who is keen to learn more about Quality function If yes we encourage you to apply to join our QA team!

This auditor role will conduct audits for both Clinical Laboratories and Clinical trials related activities. Having either a GcLP or GCLP related experiences is a must for this role. Do not worry if you only have one GxP (GcLP or GCP) experiences we will support train and guide in learning our auditing processes and skills.

This individual can travel around the Asia-Pacific to learn from our diverse group of GCP/GcLP experienced auditors conduct audits and supports QA related GCP-clinical and Clinical laboratory activities.

This candidate will support regional/global activities and should have both good written and spoken English skills is analytical able to focus is a strong teammate and has good interpersonal skills. The main responsibilities will include but are not limited to:

Auditing

• Conduct QA routine and non-routine audits of activities data facilities and processes to assure adherence to policies standards and compliance with applicable requirements. Individual will also need to support due Diligence for cause audits cross-functional system/service provider audits and able to handle sophisticated or business critical audits in a supporting or leading role. Individual will support other auditors in conduct and reporting audits.

Inspection Support

• Individual may participate and/or support in regulatory inspections

Additional Skills

• Maintains regulatory knowledge with the ability to provide critical information advice and guidance on quality issues.

• Leverage data analytics tools to analyze relevant data sources.

• Collaborate with relevant business partners to ensure robust audit plans within applicable therapeutic area program(s).

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