Global Quality Assurance Specialist Medexus

Take the lead in quality assurance as a Global Quality Assurance Specialist with Medexus Pharma. This remote position involves oversight of contract manufacturing and distribution partners in the U.S. and Canada.

In this critical role, you will support day-to-day QA activities while ensuring compliance with Health Canada GMP and U.S. FDA standards. Key responsibilities include batch record reviews, product release processes, and managing deviations and complaints. You will be instrumental in audit preparation and maintaining rigorous quality metrics for continuous improvement.

Key Responsibilities:

• Oversee contract manufacturing and logistics partner quality activities

• Review deviations, investigations, and change controls

• Author and manage QA documentation for CMO and 3PL activities

• Perform batch record reviews and ensure product compliance

• Track and trend quality metrics for ongoing monitoring

Requirements:

• Minimum of 6 years in Quality Assurance within pharma

• Knowledge of Health Canada and U.S. FDA regulations

• Proficient in electronic Quality Management Systems

• Strong attention to detail and communication

• Experience with audit preparation and management

Drive quality assurance and compliance initiatives at Medexus Pharma while leveraging your expertise in the pharmaceutical industry.
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