Québec Validation specialist

Canada, Amérique du Nord
Quality Assurance

SUMMARY

The Quality & Validation Specialist role is critical to the successful validation and compliance of our software. The primary responsibilities will be to ensure quality and compliance of our software product with respect to Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country specific), and current industry standards and best practices. Our software product is utilized by Pharmaceutical companies for the purpose of satisfying DQSA and other global compliance requirements.

RESPONSIBILITIES 

  • Maintains working knowledge of FDA, EU and other global regulations and guidance governing GxP, Computer System Validation (CSV) and GAMP5 activities
  • Ensures the quality & compliance of software development & operations activities with respect to internal procedures as well as FDA, ICH, EU and other country specific regulations
  • Generates appropriate validation documents to support customer deployments and validation processes (e.g. User Requirement Specifications, Functional Specifications, Configuration Specifications, Design Specifications, Installation Qualification, Operational Qualification, Summary Reports, etc.)
  • Executes and/or peer reviews appropriate validation documents (e.g. IQs and OQs) and prepares summary reports to customers per processes
  • Assists with hosting customer audits
  • Conducts periodic QA review of quality systems, operating procedures and policies
  • Assists in the maintenance of GxP training files and in the compliance monitoring of staff GxP training
  • Executes other duties as delegated

REQUISITE SKILLS 

  • Bachelor in a healthcare, engineering or scientific-related discipline is highly desirable
  • 3- 7 years of GxP/CSV quality assurance experience in a pharmaceuticals or biotechnology industry
  • Strong understanding of CSV related processes
  • Good understanding of FDA and global pharmaceutical regulatory requirements and implementation, ideally with experience in the area of DQSA
  • Strong knowledge of Computer System Validation in association with GxP audits
  • Effective communication (verbal and written)
  • Strong interpersonal skills, team player, and flexible without compromising quality
  • Ability to manage multiple projects in a dynamic environment

ADDITIONAL REQUIREMENTS

  • Occasional travel may be required based on the needs of our customer

What we offer 

  • Open and bright office spaces
  • Flexible hours
  • Monthly social club activities
  • Group insurance and RRSP program
  • Free coffee, of course!

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