Job Description

Responsibilities:

  • Develop, implement, and maintain Quality Management Systems (QMS) in compliance with FDA, EMA, ICH guidelines, and other regulatory requirements.

  • Ensure all processes and products comply with applicable regulatory standards, including cGMP.

  • Lead continuous improvement initiatives to enhance product quality, efficiency, and compliance.

  • Oversee validation activities, including equipment, process, and cleaning validations, ensuring compliance with industry standards.

  • Conduct thorough investigations into quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPA).

  • Plan and conduct internal audits, support external regulatory inspections, and manage responses to audit findings.

  • Evaluate and qualify suppliers, conduct supplier audits, and ensure supplier compliance with quality st...

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