Experienced Auditor in Clinical Quality and Compliance Assurance

Join as an Experienced Auditor, focusing on clinical quality and compliance assurance through meticulous audits. Utilize your knowledge of regulations and risk assessment to enhance study conduct and improve organizational standards.

The role demands a bachelor's degree and 3 years of related experience in pharmaceuticals. Your deep understanding of ICH and FDA guidelines will be pivotal as you conduct audits, assess CAPA plans, and provide training on relevant topics. Strong communication skills in both languages are essential in ensuring clarity across teams.

Key Responsibilities:

• Conduct audits following set plans and programs

• Manage audit activities including planning and reporting

• Review non-compliance and oversee CAPA processes

• Facilitate external consultant involvement in audits

• Collaborate in training development for regulatory topics

Requirements:

• Bachelor’s degree or equivalent experience

• At least 3 years in clinical quality auditing

• Comprehensive knowledge of ICH guidelines and FDA regulations

• Bilingual in French and English proficiency

• Familiarity with Microsoft Office Suite

Utilize your auditing expertise to drive compliance and performance in clinical studies and create a lasting impact.
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