Specialist, Quality Assurance (12 MONTHS CONTRACT) - #437665

Groupe Marcelle is currently looking for a Specialist, Quality Assurance for a temporary (12 MONTHS CONTRACT) 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, flexible hours, 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.
• 5 to 7 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.

TO APPLY

We invite interested individuals to use our online recruitment module by submitting an application to https://dayforcehcm.com/CandidatePortal/en-US/groupemarcelle.

DIVERSITY AND INCLUSION

Groupe Marcelle wants to offer equal employment opportunities to all. It invites women, members of visible and ethnic minorities, Aboriginals, and persons with disabilities to apply. Groupe Marcelle is also committed to pursuing the integration of diversity and making it a source of enrichment and pride for all its employees.

The use of the masculine gender in this document refers to both men and women.

Groupe Marcelle thanks all candidates for their interest; however only those selected to continue in the process will be contacted.