As a Quality Auditor you will provide independent Quality Assurance within GSK R&D by delivering the audit program, including defining the scope of audits, conducting and reporting observations. This role involves identifying compliance issues, trends within the scope of R&D to ensure compliance with relevant international regulatory agency regulations, GSK policies / procedures, and accepted principles / guidelines. Additionally, you will provide support QA activities during regulatory inspections, build solid working relationships with business stakeholders, and drive quality improvement of overall processes.
This role is primarily aligned to Good Clinical Practices (GCP).
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following :
* Independently plan, lead, and conduct routine and complex Quality Assurance audits of GSK studies, systems, GSK processes, and external vendors to assess compliance with GCP and GSK policies and procedures, and applicable local regulations.
* Document objective and process-oriented audit findings in an audit report and obtain robust CAPAs to address the findings and their root causes in a timely manner.
* Report and present findings from audits to relevant stakeholders and provide advice on compliance, quality improvement, and risk assessments.
* Support regulatory inspections for related authority inspections of GSK.
* Maintain an up-to-date and in-depth knowledge of appropriate national and international GCP legislation and guidelines and relevant GSK processes and procedures.
* Build and maintain beneficial working relationships with other quality and compliance groups and relevant internal / external customers.
* Work independently and as a member of an assigned team.
Why you? Basic Qualifications
We are looking for professionals with the following required skills to achieve our goals :
* Bachelor’s degree in related Health Science field or equivalent.
* Experience in the pharmaceutical industry and / or quality assurance.
* Previous experience in Good Clinical Practice (GCP).
* Auditing experience in the area related to Good Clinical Practice and / or experience as Clinical Research Associate.
* Knowledge of global, regional, and national regulatory requirements and regulations.
* Excellent verbal, written communication, and presentation skills.
* Demonstrated analytical skills.
* Ability and desire for frequent domestic and international travel (approximately 25-40%).
Preferred Qualifications
If you have the following characteristics, it would be a plus :
* Good knowledge of the drug development and clinical processes.
* Demonstrated experience interacting with regulatory agencies.
* Demonstrated ability to manage global projects and programs, which can contain regional focus / drivers in a culturally diverse organization.
* Audit experience in Good Pharmacovigilance Practice and / or Good Laboratory Practice.
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