Spécialiste de la qualité – Produits pharmaceutiques établies (Victoriaville) / Quality Specialist – Established Pharmaceuticals (Victoriaville)

The Opportunity

This position works out of our Victoriaville, QC location in the Established Pharmaceuticals division (EPD). In this division, we are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries.

Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management / central nervous system, and respiratory.

Reporting to the Director of Quality Assurance, the Quality Specialist is responsible for supporting the PQR (Product Quality Review) and monitoring reviews (water system, pest control, environmental monitoring, stability programs, compressed air system, cleaning program).

What You’ll Do

• Develop and lead site relevant QA programs assuring continuity of supplies and successful execution of supplier qualification based on business needs;
• Provide QA expertise for the Lactulose and associated manufacturing supply chain;
• Drive investigation of product performance issues, providing solutions supporting the site, e.g. deficiency questions;
• Support execution of product / process improvements and compliance projects for all proposed manufacturing or regulatory changes;
• Embeds the technical expertise and knowledge in the operational QA team in Victoriaville on manufacturing, tests and release of Lactulose;
• Promotes continuous improvement, innovation, simplification aligned with Abbott and EPD strategy;
• Support the continuous improvement of the product(s) with cross-functional scope;
• Embeds and drives appropriate risk-based decision making;
• Maintain the Supplier Qualification Program;
• Assist the QA Director to complete the internal and external audit program;
• Execute and / or participate in internal and external quality audits;
• Support exception events and CAPA, from a technical QA perspective ensuring events are appropriately assessed for impact and documented;
• Support process changes which have a quality or regulatory impact, ensuring timely communication and implementation of changes in line with regulatory requirements;
• Support the PQR (Product Quality Review) and monitoring reviews (water system, pest control, environmental monitoring, stability programs, compressed air system, cleaning program);
• Support and replace Quality Specialists when absent.

Required Qualifications

• Bachelor’s degree or equivalent level of education at a relevant scientific discipline or other technical / scientific, or industry experience with sufficient exposure to pharmaceutical or related industries;
• Comprehensive understanding of an Active Pharmaceutical Ingredient (API) Manufacturing and GMP’s requirements;
• Experienced of the Pharmaceutical industries or GMP controlled industries;
• Knowledge of international and local quality system and compliance legislations and standards;
• Knowledge of Microsoft tools (Excel, Word, PowerPoint, etc.);
• Facility to use computerized systems;
• Excellent oral and written communication skills in French and English;
• Sense of organization, autonomy, and leadership.
26 days ago