Quality Assurance Auditor

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Responsible for the systematic auditing and evaluation of the various aspects of a clinical projects, service, or facility to ensure standards of quality are met in compliance with the Health Canada Regulatory Requirements, internal SOPs/policies and other applicable regulatory requirements (i.e. US FDA, EMA, principle of OECD GLP, GCP, etc.). Responsible for Archiving related activities.

**KEY RESPONSIBILITIES**:

- Performance of the systematic auditing and evaluation of the various aspects of a project, service, or facility to assure management that the facilities, equipment, personnel, methods, practice, records, and controls are in compliance with ICH GCP, Food and Drug regulations (Division 5), Tri-council Policy statement, other applicable regulatory requirements (e.g., FDA, EMA), research protocols, and institutional SOPs/policies.
- Circulate audit report and discusses audit observation with concern PI / Study Director/ Department Head/ management where immediate action is required to take.
- Review audit responses and corrective & preventive actions to the audit and appropriately close the audit within compliance.
- Prepare risk-based system and process audit schedule/plan and ensure compliance of audit schedule/plan.
- Inspect each study at required intervals adequate to assure the integrity of the study.
- Prepare quality trending report, periodically notify quality issues/non-conformity, deviation, CAPA to Head QA/Management.
- Review Deviation Reports / Investigation Report and CAPA.
- Ensures that investigator (internal or external sites), service supplier/vendors, facility qualification audits are performed in compliance with internal SOPs/policies and applicable regulatory guidelines.
- Write, revise, and review Standard Operating Procedure (SOP) in compliance with Novum Standards/Policies and participate in the review cycle of the SOPs.
- Assist with the preparation, coordination and action plans resulting from regulatory inspections, or sponsor site audits.
- Identify areas for continuous improvement within the organization.
- Ensures training of Novum staff in accordance with accepted standards and practices that meet regulatory requirements.
- Provides expertise and guidance in interpreting SOPs, policies, regulatory and/or applicable regulations to assure compliance.
- Manage assigned project timelines and prioritization of tasks.
- Collects, organizes, and maintains control over Trial Master File, clinical and/or non-clinical data and other archival records in accordance with accepted standards and practices.
- Ensures that each concerned department has organized essential documents in Trial Master File in accordance with TMF checklist that allows accurate reporting, interpretation, and verification of study data.
- Develops and ensures compliance of applicable policies or procedures for data archiving at Novum, Canada.
- Evaluate performance of new/contracted service providers through vendor qualification audit.
- Performance of other duties as assigned.

**POSITION REQUIREMENTS**:
Qualifications:

- Minimum B.Sc. degree in a science discipline or equivalent is required.
- 1-3 years of working experience in Quality Control or Quality Assurance in a regulated environment is required.
- Previous experience in a lab environment or clinical research is preferred.
- Knowledge of Health Canada regulatory requirements pertaining to Good Clinical Practices (GCP), ICH Guidance Documents, and other regulatory requirements (e.g., FDA, EMA) is an asset.
- Excellent computer skills and proficient use of relevant computer software (i.e., Microsoft Outlook, Word, Excel, and PowerPoint) is required.
- Strong communication skills in English (verbal and written) are required.

Schedule:

- 8 hour shift

Ability to commute/relocate:

- Scarborough, ON: reliably commute or plan to relocate before starting work (preferred)