11 Sep
|
Logistique 3DM
|
Pointe-Claire
11 Sep
Logistique 3DM
Pointe-Claire
Our Company:
3DM Group has been a leader in logistics, fulfillment, and supply chain management for E-Commerce and pharmaceutical companies for over 30 years. We pride ourselves in providing the fastest and most cost-effective delivery of clients’ goods to consumers in order to maximize their experience.
The company is on a mission of growth and modernization of technology platforms targeting a better experience for our customers in the coming years. We are looking for an experienced QA Specialist to join us on a permanent part time basis at our Pointe-Claire office. This position offers a flexible schedule of approximately 20–25 hours per week.
:
The QA Specialist is responsible for overseeing and maintaining 3DM Group’s quality assurance and compliance activities, ensuring adherence to company standards, client requirements, and applicable regulations. The role works cross-functionally with departments to maintain quality systems, identify risks and quality concerns, and ensure appropriate corrective actions are implemented.
Duties/Responsibilities:
Responsibilities and duties include, but are not limited to:
- Establish, maintain, and monitor company quality standards, quality systems, SOPs, work instructions, training records, and controlled documentation.
- Manage adherence to client-specific SOPs, Technical Quality Agreements (TQAs), and quality requirements.
- Ensure compliance with applicable Health Canada, GMP, pharmaceutical, and other regulatory requirements.
- Conduct internal audits and facility inspections and coordinate client and regulatory audits.
- Investigate deviations, complaints, temperature excursions, quality issues, and other non-conformances; conduct root-cause analysis and oversee CAPAs.
- Oversee pharmaceutical QA activities including change control, recalls, quarantine, product destruction, retention samples, and temperature-controlled activities.
- Maintain required quality and regulatory documentation, records, renewals, and compliance activities.
- Ensure applicable GMP-related preventative maintenance programs and quality requirements are followed.
- Support supplier qualification and monitoring in accordance with applicable QA standards and procedures.
- Monitor changes to applicable regulatory requirements and communicate relevant updates internally.
- Support client quality and compliance requirements, including audits, questionnaires, documentation requests, and onboarding activities.
- Ensure quality management reports are reviewed with management and alert the COO and/or President of significant quality or compliance concerns.
Maintain an annual Quality Management Plan with a focus on continuous improvement.
Skills and Requirements:
- Minimum of 5 years of experience in Quality Assurance and/or Compliance.
- Bachelor’s degree in a science-related field, in accordance with applicable Health Canada requirements.
- Experience in pharmaceutical distribution, warehousing, logistics, or another regulated environment.
- Strong knowledge of quality systems, SOPs, audits, CAPAs, root-cause analysis, and regulatory compliance.
- Knowledge of Health Canada regulations and GMP requirements.
- Excellent communication and organizational skills.
- Excellent attention to detail and accuracy.
- Proficiency in Microsoft Office and general computer applications.
- Bilingual in French and English, both written and spoken.
- Ability to manage priorities and work both independently and collaboratively across departments.
📌 Quality Assurance Specialist (Pointe-Claire)
🏢 Logistique 3DM
📍 Pointe-Claire