Quality Assurance Auditor

**Overview**
Responsible for systematic auditing and evaluation of the various aspects of clinical projects, facilities, equipment, personnel, methods, practices, records, controls and services to ensure compliance with the Health Canada Regulatory Requirements, Novum approved standards/procedures and other applicable regulatory requirements (i.e. US FDA, EMA, principle of OECD GLP). Responsible for archive related activities.

**Responsibilities**
- Assisting in monitoring, systematic auditing and evaluation of various projects, service, facilities, equipment, personnel, methods, practice, records, and controls, assuring controls are in conformance with the ICH, Food and drug regulations (division-5), tri council policy, EMA, Research protocols and institutional SOP/Policies.
- Circulate audit report and discuss audit observation with concern QA staff if required and further discuss it with concern PI/Study director/department head /management if any immediate action is required.
- Review audit responses and implement any corrective and preventive actions in coordination with QA staff. To audit the compliance check to various QA observations.
- Perform audits as per the system and process audit schedule/plan and ensure compliance with audit schedule/plan.
- Inspect each non-clinical laboratory study at required intervals adequate to assure the integrity of the study.
- Assist in preparing the quality trending report.
- Reviewing Deviation Reports, Investigation Reports and Corrective Actions in assistance with QA staff.
- Write, revise, and review Standard Operating Procedure (SOP) in compliance with Novum standards/policies and participate in the review cycle of the SOPs.
- Assist in managing Sponsor audits and Regulatory inspections and in responding to the queries from inspection audits.
- Assist in preparation of QRM and managing QRM meetings and deliverables.
- Assist in tracking Change Control for documents, systems and processes.
- Review Method Validation and Bioanalytical reports in accordance to SOPs, Regulatory and Sponsor requirements.
- Ensure that Method Validation and Bioanalytical reports accurately reflect raw data.
- Assist in preparation, coordination and action plan resulting from regulatory inspections or client site audits.
- Assist in Identifying the areas for continuous improvement within the organization.
- Ensure training of Novum staff with regard to accepted standards and practices that meet regulatory requirements.
- Assist the central archivist in organizing and maintaining control over Trial Master File, clinical and/or non-clinical data and other archival records in accordance with accepted standards and practices.
- Evaluate performance of new/contracted service providers through vendor qualification audits.
- Managing Assigned project timelines.
- Perform other duties as assigned.

**Qualifications**
- Bachelor’s degree in scientific discipline or equivalent.
- 1-3 years of working experience in Quality Assurance, preferably in CRO or clinical research environment.
- Knowledge of Health Canada regulatory requirements pertaining to Good Clinical Practices (GCP) and ICH Guidance Documents, and other regulatory requirements ( e.g. FDA, EMA).
- Ability to read, write, analyze & interpret technical procedures and governmental regulations.
- Demonstrated proficiency with MS Office Suite of products. (Microsoft Outlook, Word, Excel, PowerPoint).
- Strong command of the English language. Excellent verbal, written and interpersonal skills are required.

Schedule:

- Monday to Friday

Work Location: In person