Quality Portfolio Specialist, Audits

Bayshore•Markham, ON

35d

About The Position

The Quality Portfolio Specialist, Audits will support the entire audit lifecycle for internal and external audits, leading to greater compliance across the division.

Requirements

Professional Scientific degree and/or combination of Quality, Regulatory Certification.
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.
Well versed with GxP documents and GxP regulations.
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.

Nice To Haves

Experience working in Pharmaceutical GMP Quality and/or Regulatory environment is desired.
Quality audit certification is an asset.

Responsibilities

Maintains Quality Management System policies and procedures in line with GxP regulations, ISO standards and Provincial College of Pharmacy regulations.
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.