Quality Assurance Coordinator

4 weeks ago

Toronto, Ontario, Canada Bayshore HealthCare Full time

Job Title: Quality Assurance Coordinator

Job Summary:

The Quality Assurance Coordinator will assist in the administration of quality systems and improvement initiatives as it relates to quality deviations, corrective and preventive actions, and document management.

Key Responsibilities:

  • Assist in the implementation of quality improvement initiatives across the Specialty Program Portfolio.
  • Run document change control meetings and manage the review and approval process for documents, ensuring version control.
  • Support the administration and training initiatives on Quality Management Systems, including document and risk management processes.
  • Manage and maintain the division-wide Document Management System (DMS).
  • Assist in creating and revising Specialty Program Portfolio standard policy documents and standard operating procedures.
  • Maintain the Document Review Tracker and ensure departmental policy documents are up to date.
  • Notify Program teams of upcoming renewals and facilitate approvals.
  • Manage document repository access rights.
  • Support and educate teams on conducting root cause analysis, investigations, and writing effective CAPAs.
  • Work closely with the Quality event owners to ensure Quality events are properly documented in the system, root cause analysis is conducted appropriately, and corrective and preventive actions are simple, effective, and achievable.
  • Classify deviations and conduct effectiveness checks.
  • Monitor CAPA plan timelines for completion, conduct follow-ups as needed, and close QEs as per the due date.
  • Support audit/inspection document readiness-related activities.

Requirements:

  • Professional degree and/or advanced background in a Health discipline and/or Quality Certification.
  • Minimum two to three (2-3) years of previous experience working with Quality initiatives in a healthcare setting.
  • Experience working in a Pharmaceutical GMP environment is an asset.
  • Experience using Trackwise QMS system is an asset.
  • Well-versed with GxP documents.
  • Effective business writing skills are required.
  • Effective technical writing skills in writing policies, standard process documents, work instructions, etc.
  • Experience in handling internal and external Pharma audits and/or board of health inspections, including but not limited to GVP inspections is an asset.
  • 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 Systems, and Quality Management System.
  • Knowledge of GxP guidelines, GDP (Good Documentation Practices), GMP (Good Manufacturing Practices), GCP (Good Clinical Practice), Health Canada GVP (Good Pharmacovigilance Practices), as well as ASQ quality standards, and ISO standards.
  • Bilingual (French/English) is an asset.
  • Ability to multi-task and balance day-to-day quality operations with tight timelines.
  • Must be detail and process-oriented.
  • Strong interpersonal and decision-making skills.
  • Excellent written and verbal English communication skills; fluent in quality terminology.
  • Team player with the ability to collaborate productively.
  • Willing and able to work independently and in a collaborative team setting.

About Bayshore HealthCare:

At Bayshore HealthCare, our commitment to Equity, Diversity & Inclusion is our strength. This is how we bring our vision of being the difference in the lives of those we care for, work with, and in our communities. We have a great sense of pride in creating a culture of belonging, where individual differences are embraced and celebrated, through programs, resources, and policies that support each individual's purpose, potential, and wellbeing.

Bayshore operates in accordance with the Accessibility for Ontarians with Disabilities Act, and applicable Provincial Human Rights Codes.

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