Quality Assurance Consultant for Compliance
1 month ago
The Associate Consultant—Compliance Services role focuses on applying your GMP knowledge and experience to various projects, ensuring clients are confident in the project approach and execution timing. Our consultants work independently within a team environment to ensure timely completion of activities.
We seek consultants who can apply their in-depth quality and compliance knowledge, along with out-of-the-box thinking, to challenging projects with our clients. Our projects cover deviation investigations, auditing, management of quality systems, training delivery, batch document review, product releases, equipment validation, computer validation (including data integrity), and related tasks for pharmaceuticals, biologics, NHPs, and Medical Devices.
In this broad-based role, you will support assigned projects, meeting client needs. The role prioritizes, plans, organizes, and executes projects related to quality and compliance of health products to ensure smooth implementations. You may coordinate or work with client personnel to meet project goals.
Reporting to the Manager, Quality Services or Compliance Services, the Associate Consultant is responsible for:
- Prioritizing and managing compliance projects
- Completing critical assessments of data and documents to identify gaps compared to regulatory requirements
- Communicating project milestones on a monthly basis
- Completing client-assigned tasks: deviation investigations, review of importer documentation
- Developing documentation as required by the project: SOPs, protocols, reports, APQRs, etc.
- Releasing product to market
- Assisting with hosting Health Canada audits, corporate audits, and self-inspections
If you're a Quality Assurance professional in the Pharmaceutical industry, we offer an environment and exposure to the type of work you want to do.
Requirements:
We require 1–3 years of industry experience in the following areas:
- Change/CAPA management
- Deviation investigations
- Master manufacturing/batch record review and lot release
- Annual Product Quality Reviews
- Stability review and assessment
- APQR review and assessment
- Exposure to Health Canada audits, corporate audits, and self-inspections
Estimated Salary: $60,000 - $80,000 per year, depending on location and experience.
We welcome and encourage applications from people with disabilities. Accommodations are available upon request for candidates participating in all aspects of the selection process.
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