Quality Assurance Specialist at Medexus Pharma

Elevate quality standards with Medexus Pharma as a Global Quality Assurance Specialist focusing on oversight of external manufacturing and distribution partners. This remote role includes essential quality processes and regulatory compliance.

As a Global Quality Assurance Specialist at Medexus Pharma, you will ensure compliance with Health Canada GMP and U.S. FDA cGMP standards.

Your role includes managing batch record reviews, product release, and addressing deviations and complaints. You will serve as a key player in audit preparations and continuous process improvement aimed at enhancing patient care.

Key Responsibilities:

• Oversee Contract Manufacturing Organizations (CMOs) and logistics partners

• Review deviations, investigations, and change controls for compliance

• Author internal deviations and manage related QA documents

• Perform batch record reviews and ensure product release accuracy

• Handle product complaint documentation and investigations

Requirements:

• Bachelor’s degree or diploma in a scientific discipline

• Minimum 6 years of QA experience in pharmaceuticals

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

• Proficiency with Quality Management Systems (QMS)

• Strong organizational and communication skills

Bring your expertise in quality assurance to support Medexus Pharma's commitment to patient health and safety.
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