Quality Systems Specialist / Spécialiste, Systèmes Qualité (Canada)

The role of the Quality Systems Specialist (QSS) is to actively contribute to the maintenance of 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.

This role will be perfect for you if

• You have strong experience in Quality Systems (QMS) within a GxP environment and are confident managing CAPAs, deviations, and documentation.

• You enjoy conducting audits, collaborating with stakeholders, and contributing to inspection readiness and continuous improvement.

• You thrive in a fast-paced, growing organization where you can make a tangible impact on quality and compliance.

More specifically, the Quality Systems Specialist must

• Executes audits in accordance with the established audit program.

• Performs audit activities such as planning, conducting and writing of audit report.

• Issues observation/recommendations and reviews appropriateness of responses/CAPA plan. Follow up on CAPA plan until closure.

• Reviews the NCs related to quality systems and tracks trends and progress of CAPA closing. Contribute to activities related to quality indicators.

• Contributes to consultation on quality systems related issues. Can participate in process improvement initiatives.

• Contributes to training content related to quality systems and GxP topics. Can provide training to Indero employees.

• Completes RFI requested by clients. Can assist in client qualification audits and regulatory inspections including mock inspection activities.

• Contributes to the writing/revision of quality documents.

Employees may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.

• Bachelor degree in a relevant discipline or equivalent experience;

• Minimum of 3-5 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 Health Canada and Food and Drug Administration (FDA) and EU regulations;

• Knowledge of GMP (an asset);

• Good knowledge of the Microsoft Office Suite (Word, Excel, PowerPoint);

• Knowledge of artificial intelligence applications is an asset (e.g., Copilot).

• Good organization skills and ability to adapt to a rapidly growing environment;

• Bilingual: French and English, written and spoken;

• Willing to travel 10-20% of the time

• Experience in clinical quality and dermatology/rheumatology (an asset).