JOB SUMMARY
The Quality Portfolio Specialist, Audits will support the entire audit lifecycle for internal and external audits, leading to greater compliance across the division.
DUTIES AND RESPONSIBILITIES
- Maintains Quality Management System policies and procedures in line with GxP
- regulations, ISO standards and Provincial College of Pharmacy regulations.
- Be responsible for the following external audits and self-inspection readiness related activities:
- Maintains key audit/inspection readiness documents to ensure the most up to date version and correct documents are available in the repository.
- Provides support with the coordination of internal self-inspections and external audits including but not limited to audit scheduling, pre-audit training, logistics, audit runner, document follow-up, and CAPA plan & tracking.
- Provides guidance and educates teams on conducting root cause analysis, investigations and writing effective CAPAs.
- Participates in internal review of audits documents.
- Supports the completion of Pre-Audit Surveys, Due-Diligence Compliance Questionnaires, Vendor Qualification Questionnaires, RFP Questionnaires, Third Party Risk Assessment Questionnaires and ABAC Questionnaires received from Pharma partners.
- Supports in identifying compliance gaps and developing a plan to eliminate/mitigate compliance gaps.
- Assists in creating and revising Specialty Program Portfolio and Division wide
- standard policy documents and standard operating procedures.
- Utilizes technical and business writing skills to effectively communicate
- process changes across the Specialty Program Portfolio.
- Monitors Health Canada, ISO and Provincial College of Pharmacy/NAPRA regulatory and quality requirements and proactively adapt the internal processes to meet the changing requirements.
- Must be able to interact with all levels of internal stakeholders and build a good rapport with internal stakeholders.
- Performs other quality and compliance related division wide duties as assigned.
