Regulatory Compliance Specialist
2 weeks ago
Job Summary
The Quality Assurance Associate Consultant role focuses on applying your GMP knowledge and experience to complex projects, ensuring client confidence in approach and execution timing. This independent role within a team environment prioritizes timely activities and out-of-the-box thinking to drive project success.
About the Role
We are seeking consultants who can apply in-depth quality and compliance knowledge to challenging projects with our clients. Projects cover deviation investigations, auditing, quality system management, training delivery, batch document review, product releases, equipment validation, and computer validation related to pharmaceuticals, biologics, NHPs, and Medical Devices.
Key Responsibilities
In this broad-based role, you will support assigned projects, meeting client needs. Key responsibilities include prioritizing and managing compliance projects, completing critical assessments of data and documents, communicating project milestones, and developing project documentation.
Requirements
1-3 years industry experience in change/CAPA management, deviation investigations, master manufacturing/batch record review, annual product quality reviews, stability review and assessment, APQR review and assessment, and exposure to Health Canada audits, corporate audits, and self-inspections is required.
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