Quality Specialist
Bayshore HealthCare View all jobs
- Markham, ON
- Permanent
- Full-time
The Quality Specialist, under the direction of the Manager, Quality & Risk Management, will support the implementation and maintenance of the Quality Management System (QMS) and Document Management System (DMS), Learning Management System (LMS), participate in quality improvement initiatives, and develop policies, procedures, and education materials to support the business. The incumbent will support the assigned business lines through Quality Events, Risk Management, Privacy Management, and the Internal and External Audit Program. In addition, the Quality Specialist collaborates with Supply Chain and Logistics teams to ensure adherence to Good Distribution Practices (GDP) and other regulatory requirements for pharmaceutical distribution. This includes monitoring supply chain processes, supporting vendor qualification, managing temperature-controlled logistics, and investigating supply chain-related quality events. Occasionally, this position may provide support to other business lines as deemed appropriate by the Quality Management team. Work Arrangement: This is a hybrid role, requiring a minimum of three mandatory on-site days per week. Based on business needs, a full on-site presence may be required in exceptional circumstances (e.g., audits, recalls, or other emergencies).DUTIES AND RESPONSIBILITIES
- Participates in the development, implementation and maintenance of Quality Management System and Document Management System.
- Ensure processes meet established quality standards and follow all applicable regulatory and legislative requirements and are version-controlled via the document change control process.
- Reviews and updates policies, SOPs, and work instructions; contributes to the development of new documents and evaluates their effectiveness. Ensures proper training assignments for newly implemented policies and procedures and communicates changes to all employees.
- Supports management of quality events (deviations). Conducts root cause analysis, investigations and ensures the CAPA plan is effective and closes on time. This will require education, coordination, and collaboration across the team with all internal stakeholders. Assists with quality event trends analysis and resulting improvement initiatives.
- Identifies training needs, participates in the development of training materials, and leads training to meet quality management standards and contractual requirements.
- Educates internal stakeholders on key quality deliverables and identifies process improvements to increase efficiency, effectiveness, and quality.
- Liaises with Quality leads from other business lines to collaborate on initiatives or adapt mutually beneficial processes.
- Collaborates with Supply Chain and Logistics teams to ensure compliance with Good Distribution Practices (GDP) and other regulatory requirements for pharmaceutical wholesale and distribution.
- Monitors and reviews supply chain processes, including procurement, storage, transportation, and delivery, to ensure adherence to quality standards and minimize risk of product damage or contamination.
- Supports vendor qualification and management for suppliers, transportation providers, and
- Assists in managing temperature-controlled logistics and monitoring systems to maintain product integrity throughout the distribution process.
- Participates in investigations related to supply chain deviations, shipping discrepancies, and product returns, ensuring timely resolution and implementation of corrective actions.
- Works with inventory management teams to ensure accurate documentation, traceability, and reconciliation of pharmaceutical products in compliance with regulatory requirements.
- Performs other duties as assigned.
➢ EDUCATION
- Bachelor’s degree preferably in a health-related field.
- ASQ Quality certification, ISO Auditor Certification, or equivalent quality certification will be considered an asset.
- Completion of Quality Management, Risk Management, or related courses is preferable.
- At least 3-5 years of experience in quality assurance, preferably in the healthcare or life sciences industry.
- Experience in supply chain and logistics operations, preferably in pharmaceutical wholesale and distribution, including knowledge of Good Distribution Practices (GDP)
- Experience in the development of policies, SOPs and WIs.
- Knowledge of inventory management, cold chain logistics, and vendor qualification processes.
- Experience in managing deviations, RCA, and CAPAplans.
- Experienced in using quality systems like QMS, DMS, LMS, as well as ERP & CRM applications.
- Understanding QMS Validation is an asset.
- Previous experience working with Health Canada on the medical device establishments would be preferred.