Quality Systems Specialist - Remote

Overview

The role of the Quality Systems Specialist (QSS) is to actively contribute to the maintenance of a compliant quality system. The QSS also conducts internal audits and can assist in regulatory inspections and client audits. Additional activities in the sector of computerized systems and IP release can be assigned based on role and qualification.

In Short

• Executes audits in accordance with the established audit program.
• Performs audit activities such as planning, conducting, and writing audit reports.
• Issues observations/recommendations and reviews appropriateness of responses/CAPA plans.
• Tracks trends and progress of CAPA closing related to quality systems.
• Contributes to consultation on quality systems related issues.
• Contributes to training content related to quality systems and GxP topics.
• Completes RFIs requested by clients.
• Contributes to the writing/revision of quality documents.

Requirements

• Bachelor's degree in a relevant discipline or equivalent experience.
• Minimum of 3 years’ experience in quality assurance in the pharmaceutical industry or clinical research.
• Good knowledge of ICH guidelines and applicable regulations (Health Canada, FDA, EU).
• Ability to communicate effectively both orally and in writing.
• Good knowledge of good clinical practices and applicable GxP regulations.
• Knowledge of GMP (an asset).
• Good knowledge of Microsoft Office Suite.
• Knowledge of artificial intelligence applications (an asset).
• Bilingual: French and English, written and spoken.
• Willing to travel 10-30% of the time.

Benefits

• Flexible work schedule.
• Permanent full-time position.
• Complete benefits (medical, dental, vision, RRSP, vacation, personal days).
• Ongoing learning and development.