12 Oct
|
Brunel
|
Greater Toronto Area
12 Oct
Brunel
Greater Toronto Area
Quality and Patient Safety Associate (12-month contract)
Remote – Toronto, ON
Introduction
Our client, a leading organization in the pharmaceutical industry, is seeking a Quality & Patient Safety Associate to join their team on a 12-month contract basis. This role will support quality assurance, quality control, and patient safety activities, ensuring compliance with internal procedures and applicable regulatory requirements. The successful candidate will work cross-functionally with Quality, Pharmacovigilance, Regulatory Affairs, and Medical Affairs teams while supporting day-to-day operational and compliance-related activities.
This position is fully remote, with the expectation of attending the office approximately once per month.
Responsibilities
- 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 escalate 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.
Requirements
- Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, or a related discipline.
- 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.
- Ability to manage multiple priorities in a fast-paced setting.
- Strong verbal and written communication skills.
- 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.
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About Us
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📌 Quality and Patient Safety Associate (Greater Toronto Area)
🏢 Brunel
📍 Greater Toronto Area