An innovative pharma company has an urgent vacancy for a talented Quality Manager to lead the QA/QC team and activities for this API site for all matters relating to EU QP release.
Role:
• Lead the GMP compliance efforts for API production process related to site
• Lead the GMP compliance efforts for EU QP Release process (Drug Product Release)
• Promote a culture of quality and continuous improvement across
the organization
• Monitor and audit manufacturing for GMP compliance
• Develop, manage, and maintain appropriate procedures to ensure regulatory compliance.
• Manage any third parties to which functions have been outsourced
• Maintaining a Quality Risk Management system to ensure that risks are adequately
• Improving operational performance of QA and QC departments by coaching team members
• Apply modern principles of quality systems and strategic planning to products
• Supervise Quality Assurance, Quality Control, Drug Product Release and Training functions.
Requirements:
• Bachelor’s Degree in Science
• 10+ years experience in an API/pharmaceutical Quality Assurance/Quality Control environment.
• Five (5) years of progressive leadership or supervisory experience in a Quality
Assurance function of the pharmaceutical industry required
• Demonstrated ability to implement continuous improvement methods. Six Sigma / Lean experience or qualification an advantage.
