23 Oct
|
Brunel
|
Toronto
Quality and Patient Safety Coordinator (12-month contract) Remote – Toronto, ON Our client, a leading organization in the pharmaceutical industry, is seeking a Quality & Patient Safety Coordinator to join their team on a 12-month contract basis. This role will support quality assurance, quality control and safety-related activities, ensuring compliance with internal procedures and applicable regulatory requirements. The successful candidate will work cross-functionally across quality, safety, regulatory, and medical teams, providing broad support while managing a wide range of day-to-day operational activities.
This role suits a versatile, flexible professional who thrives on multitasking in a rapid-paced environment. Support pharmacovigilance and quality processes in accordance with company procedures and regulatory requirements. Review, process, and maintain safety and quality-related documentation, ensuring accuracy and completeness.
Monitor, document, and elevate product complaints, adverse events, deviations, and other quality-related incidents as required. Assist with investigations, root cause analysis, corrective and preventive actions (CAPAs), and follow-up activities. Maintain accurate records and data within relevant quality and safety management systems.
Collaborate with cross-functional stakeholders, including regulatory affairs, medical affairs, quality assurance, and operations teams. Support audits, inspections, and compliance activities, including document preparation and follow-up actions. Ensure adherence to applicable regulations, guidelines, standard operating procedures, and quality standards.
Respond to internal and external inquiries related to quality and product safety processes. Manage 3PL documentation request follow-ups and metrics/TempTale reconciliation, including pre-review of temperature excursion and destruction records. Maintain reference document management processes, including all Veeva QC document uploads and approvals (e.g., Manage shipping notifications and forecasts, including pre-review of Certificates of Analysis (CoAs) for tickets and coordinating ticket requests with sites, assessing quality impact.
Provide broad, hands-on administrative support to the quality team, flexibly balancing shifting priorities across QA, PV, and QC functions. Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, or a related discipline. ~3-5 years of experience across patient safety, quality assurance, and quality control, within pharmaceutical/biotechnology environments. ~ Demonstrated experience in project management, including planning, execution, and coordination of cross-functional activities. ~ Experience managing change controls, deviations, and supporting internal and external audits within a regulated environment. ~ Understanding of GxP, pharmacovigilance, and/or quality management principles. ~ Experience reviewing technical, scientific, or regulated documentation with strong attention to detail. ~ Proficiency with electronic quality, safety, or data management systems is considered an asset. ~ Experience supporting both quality and pharmacovigilance activities within a small or mid-sized organization is considered an asset. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services. #
📌 Quality and Patient Safety Associate (Toronto)
🏢 Brunel
📍 Toronto