Clinical Quality Assurance Professional
Há 5 dias
Job Opportunity: Clinical Quality and Compliance Auditor
As a Senior Auditor, you will play a key role in ensuring compliance with clinical quality and regulatory standards. Your primary responsibility will be to establish and execute audit plans, assess compliance in study conduct, and provide expert guidance on GxP consultation.
This is an ideal opportunity for you if you possess a deep understanding of norms and regulations, combined with a creative and inquisitive mindset. You should be comfortable working collaboratively within a small team, contributing your expertise to complete various tasks and special projects.
Key Responsibilities- Implement robust audits plans and execute audits in accordance with the established audit program.
- Act as a lead/mentor for the conduct of audit activities, including site, studies, internal, and vendors audits.
- Coordinate and conduct clinical sites audits with the project management team.
- Participate in auditor training, providing guidance on audit techniques, risk assessment, and system approach.
- Formulate observations/recommendations and review appropriateness of audit responses/CAPA plan and track progress.
Additional responsibilities may include developing training content for SOPs, regulations, and GxP topics, and providing training to employees. A bachelor's degree in a relevant discipline or equivalent experience is required, along with 5-10 years' experience in the pharmaceutical or research industry (more specifically in clinical quality). Fluency in English is required, with proficiency in additional languages considered a valuable asset.
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