Quality Assurance Coordinator (1-Year Contract)

About The Role

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

PLEASE NOTE: This is a 1 year contract position.

a Day In The Life

• In-accordance with GMP and GDP guidelines, assist in running document change control meetings and in effectively managing the review & approval process for documents, ensuring version control.
• Assist in creating and revising Specialty Program Portfolio standard policy documents and standard operating procedures.
• Notify Program teams of upcoming renewals and facilitate approvals.
• Manage document repository access rights.
• Support the administration and training initiatives on Quality Management Systems, including document and risk management processes.
• Support the following audit/inspection document readiness related activities:
• Assist in the implementation of quality improvement initiatives across the Specialty Program Portfolio.
• Maintain Annual Document Review Tracker and ensure departmental policy documents are up to date.
• Support Quality team in the management and maintenance of division wide Document Management System (DMS)

 Maintain key audit/inspection readiness documents to ensure the most up- to-date version and correct documents are available in the repository at all times.

 Act as a document runner during internal and external audits to retrieve audit related documents, as requested.

• 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 working in Pharmaceutical GMP environment is an asset.
• Knowledge of current Pharmaceutical Quality Systems and Compliance standards.
• Professional degree and/or advanced background in 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 in CAPA planning and follow-ups.
• Perform other duties as assigned.
• Experience working with Quality Systems including but not limited to: Document Management Systems, Change Control System, and Quality Management System.
• Support and educate teams on conducting root cause analysis, investigations and writing effective CAPAs.
• Effective technical writing skills in writing policies, standard process documents, work instructions etc.
• Well versed with GxP documents.
• Effective business writing skills are required.
• Must be able to interact with all levels of internal stakeholders and build a good rapport with internal stakeholders.
• Knowledge of ICH (International Conference on Harmonization), GDP (Good Documentation Practices), GCP (Good Clinical Practice), GMP (Good Manufacturing Practices), Health Canada GVP (Good Pharmacovigilance Practices), Health Canada guidelines for Reporting Adverse Reactions to Marketed Health Products, Global PV regulations, Pharmacovigilance post marketing compliance audits, Medical Information (MI) practices, ASQ, and ISO guidelines.
• Experience using Track wise QMS system is an asset.
• Monitor Health Canada regulatory and quality requirements and proactively adapt the internal processes to meet the changing requirements.

Primary Location

ON-Mississauga