Job Description

Description :

RESPONSABILITIES & DUTIES

The Head of Quality & Compliance establishes and maintains high quality and productivity standards ensures site GMP operations are in compliance, while maintain an efficient workflow to facilitate the operational excellence.

• Responsible for the release of products on Canadian market including timely QA review, approval of products in accordance with applicable procedures and regulations that govern the products manufactured and distributed by Pharmascience.
• Provide regular updates and recommendation to the company senior management with regard to the status of Quality KPIs and projects. Recommends and implements plan of action to sustain KPI compliance that leads to higher quality, efficiencies and cost reduction.
• Represent company during inspection and meetings with external regulatory bodies or customers.
• Leads site team for audit preparation and execution. Hosts customer and regulatory inspections in a manner that promotes good dialogue and ensures that corrective actions are comprehensive and designed to prevent recurrence of deficiencies.
• Assists in the development and approval of Good Manufacturing Practices (GMP) policies and procedures
• Ensure APQR, CAPA, Change Control and Complaint programs are followed and monitored.
• Ensure approvals related to validations are tracked and controlled.
• Provide QA subject matter expert (SME) support for business activities.
• Reviews departmental budget for adherence to plan while maintaining an efficient organization without significant backlogs in activities.
• Fosters excellent relationships with other departments to ensure a cooperative, mutually respective environment resulting in rapid resolution of issues and achievement of goals.
• Supports Pharmascience global quality and continuous improvements initiatives.
• Ensures coaching and development of staff in order to ensure sufficient backup and depth while creating an efficient and motivated department with high quality standards and performance.

Education : Bachelor

Experience : 10 years: Minimum 10 years related experience in a pharmaceutical manufacturing company.

Pharmascience