Overview
Quality Systems Specialist/Spécialiste, Systèmes Qualité Jobs in Montreal, Canada at Indero
Position: Quality Systems Specialist / Spécialiste, Systèmes Qualité )
Location: Montreal
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.
Brand name:
Indero
Our company:
The work environment
At Indero, you will work with brilliant and driven colleagues. Our values are integrity, commitment and teamwork. We offer a stimulating work environment and attractive advancement opportunities.
As a Quality Systems Specialist, you will be eligible for the following perks:
- Flexible work schedule
- Permanent full-time position
- Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
- Ongoing learning and development
About Indero
Indero is a contract research organization (CRO) specialized in dermatology with a team of over 350 employees. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
We thank you for your application and please note that only those selected for an interview will be contacted.
Indero only accepts applicants with a work permit for Canada.
Description de poste:
Le rôle du Spécialiste des Systèmes de Qualité (SSQ) est de contribuer activement au maintien d’un système de qualité conforme. Le SSQ effectue également des audits internes et peut assister lors des inspections réglementaires et des audits clients. Des activités supplémentaires dans le domaine des systèmes informatisés et de la libération des IP peuvent être attribuées en fonction du rôle et des qualifications.
Ce rôle est parfait pour vous si :
- Vous possédez une solide expérience en systèmes qualité (QMS) en environnement GxP, incluant la gestion des CAPA, des déviations et de la documentation.
- Vous aimez réaliser des audits, collaborer avec des parties prenantes et contribuer à la préparation aux inspections et à l’amélioration continue.
- Vous évoluez avec aisance dans un environnement en croissance rapide où votre impact sur la qualité et la conformité est concret.
Plus précisément, le Spécialiste des Systèmes de Qualité (SSQ) doit:
- Effectuer des…
Title: Quality Systems Specialist/Spécialiste, Systèmes Qualité
Company: Indero
Location: Montreal, Canada
Category:
