Auditeur, qualité clinique et conformité / Auditor, Clinical Quality and Compliance, Canada

Indero•Montreal, QC

48d•Remote

About The Position

The role of the Auditor, Clinical Quality and Compliance is to perform audit-as per the audit plans, assessing/securing compliance in study conduct. This role will be perfect for you if: You approach challenges with an understanding of norms and regulations, combined with a creative and inquisitive mind You enjoy working with a small team, contributing your experience and expertise to complete a variety of tasks , including special projects You love being part of different types of audits

Requirements

Bachelor degree in a relevant discipline or equivalent experience;
minimum of 3 years’ experience in the pharmaceutical or research industry (more specifically in clinical quality)
Excellent knowledge of ICH guidelines, FDA and Health Canada regulations. Good knowledge of EU standards.
Master the overall audit process including a systems-oriented approach, investigation/root cause determination and CAPA process.
Ability to communicate effectively both orally and in writing;
Good organization skill and ability to adapt to a rapidly growing environment;
Bilingual: French and English, written and spoken;
Good knowledge of the Microsoft Office Suite (Word, Excel, PowerPoint);
Willing to travel 10-30% of the time

Responsibilities

Execute the audits in accordance with the established audit program and the study-specific audit plan.
Perform audit activities such as planning, conduct and report writing (sites, studies, internal and vendors). Takes a risk-based approach for the sampling verifications to be performed.
Can facilitate audit planning and conduct when external consultant is involved.
Issue observations/recommendations and review appropriateness of audit responses/CAPA plan and track the progress.
Review and assess non-compliances, adequacy of CAPA plan and track the progress of action items. Can participate to investigations where needed.
Contribute to GxP consultation.
Participate in sponsor study-specific audits and regulatory inspections including mock inspection activities.
Work closely with the Quality System group for internal, vendor audits and periodic risk review of vendors. Can also be involved in client’s qualification audits and review of SOPs.
Contribute to training content for topics related to SOP, regulations and GxP. Can provide training to Indero's employees.
Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.