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.
QUALIFICATIONS
EDUCATION
• Professional Scientific degree and/or combination of Quality, Regulatory Certification.
EXPERIENCE
• Minimum three (3) years of previous experience working with Quality initiatives in a healthcare setting.
• Experience in handling the Regulatory Board of Health Inspections and Global Pharma Compliance Audits is required.
• Experience working in Pharmaceutical GMP Quality and/or Regulatory environment is desired.
• Well versed with GxP documents and GxP regulations.
• Quality audit certification is an asset.
• Effective business writing skills are required.
• Effective technical writing skills in writing policies, standard process documents, work instructions.
• Experience in CAPA planning and follow-ups.
• Knowledge of current Pharmaceutical Quality Systems and Compliance standards.
• Experience working with Quality Systems including but not limited to: Document
• Management Systems, Change Control System, and Deviation/CAPA Management Systems.
• Knowledge of GDP (Good Documentation Practices), GMP (Good Manufacturing Practices), Health Canada GVP (Good Pharmacovigilance Practices), NAPRA regulations and ISO standards
