Job Description

ABOUT THE ROLE: The Bilingual 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.
A DAY IN THE LIFE:

• Assist in the implementation of quality improvement initiatives across the Specialty Program Portfolio.
• 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.
• Support the administration and training initiatives on Quality Management Systems, including document and risk management processes.
• Support Quality team in the management and maintenance of division wide Document Management System (DMS)
• Assist in creating and revising Specialty Program Portfolio standard policy documents and standard operating procedures.
• Maintain Annual 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 the following audit/inspection document readiness related activities:

\xef\x82\xa7 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.
\xef\x82\xa7 Act as a document runner during internal and external audits to retrieve audit related documents, as requested.

• Support and educate teams on conducting root cause analysis, investigations and writing effective CAPAs.
• Monitor Health Canada 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.
• Perform other duties as assigned.

Bayshore is committed to a high quality and safe environment for both our staff and clients/patients. At Bayshore all new hires must have received the full series of a COVID-19 vaccine or combination of COVID-19 vaccines approved by Health Canada (e.g., two doses of a two dose vaccine series or one dose of a single- dose vaccine series); AND have received the final dose of the COVID-19 vaccine at least 14 days prior to the official start date of hire. Medical exemptions or any other kinds of requested exemptions based upon Human Rights Code will be considered on a case-by-case basis. Bayshore operates in accordance with the Accessibility for Ontarians with Disabilities Act, 2005 and applicable Provincial Human Rights Code

Job Qualification

• 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 working in Pharmaceutical GMP environment is an asset.
• Experience using Track wise 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 System, and Quality Management System.
• 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.

MUST BE BILINGUAL IN FRENCH Bayshore is committed to a high quality and safe environment for both our staff and clients/patients. At Bayshore all new hires must have received the full series of a COVID-19 vaccine or combination of COVID-19 vaccines approved by Health Canada (e.g., two doses of a two dose vaccine series or one dose of a single- dose vaccine series); AND have received the final dose of the COVID-19 vaccine at least 14 days prior to the official start date of hire. Medical exemptions or any other kinds of requested exemptions based upon Human Rights Code will be considered on a case-by-case basis.