Quality Assurance Specialist

Groupe Marcelle is currently looking for a Specialist, Quality Assurance for a permanent full-time position.

Reporting to the Supervisor, Quality Assurance, the Specialist, Quality Assurance is responsible for ensuring compliance with standards and Good Manufacturing Practices (GMP) within the facility. The person in this role manages the Quality Assurance system to comply with applicable regulatory requirements.

WORK ENVIRONMENT

• Workplace: 9200, Côte-de-Liesse Road, Montreal, Quebec (mainly on site, given the operational nature of the role).
• Growing company.
• A dynamic team of professionals.
• Benefits: Competitive base salary and generous benefits package (including flexible hours, medical and dental insurance, health savings account, pension plan, telemedicine, employee assistance program, bonus, and holiday vacation).
• Employee discounts on all Marcelle Group products.

YOUR RESPONSIBILITIES WILL BE

• Manage the following quality processes: Non-Compliance (RNC, RI, RLC), Corrective and Preventive Actions (CAPA), Change Controls (CC), Deviations.
• Participate in investigations and inquiries related to the above processes.
• Ensure continuous improvement of existing quality processes.
• Evaluate and release drug files for raw materials, packaging components, bulk products, semi-finished products, finished products.
• Draft procedures and appendices within the quality documentation system, deploy them and make the necessary revisions.
• Implement the training program.
• Support Production departments.
• Approve stability protocols.
• Develop and maintain a computerized quality management system.
• Manage self-inspections, follow-up action plans and schedules, and monitor internal and external audits.
• Collaborate on regulatory audits and implement corrective action plans.
• Carry out or support various validations.
• Update key performance indicators (KPIs).
• Provide support to QA Coordinators.
• Maintain pharmacovigilance process including literature search, summary reports and cosmetovigilance.
• Investigate customer and consumer quality complaints and draft annual reports.

WE WOULD LIKE TO MEET YOU IF YOU HAVE

• Bachelor's or technical degree in quality assurance or related fields.
• Between three (3) and five (5) years' experience in quality assurance process management within the pharmaceutical, food or cosmetics industry.
• Knowledge of Quality Assurance and GMP principles.
• Knowledge of the various regulations in force.
• Good computer skills: Word, Excel, Outlook, Visio, etc.

AND IF YOU ARE

• Bilingual, English and French, oral and written required.
• Organized, autonomous, and like to take initiative.
• Skilled in problem-solving.
• Good at communication and have strong interpersonal skills.
• A natural leader.
• Team-oriented.

The task and responsibilities listed above are summaries and indicatives.