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Quality Assurance Manager - GMP

Company: Hydrogen UK Ltd
Location: Philadelphia
Posted on: March 20, 2023

Job Description:

Our pharmaceutical client is looking for a Quality Assurance Manager. This role will be responsible for GMP related activities, including but not limited to, vendor audits, QMS management, and managing controlled documents. Experience with large molecules is a requirement for this role. This role requires travel to external partner sites.Key Responsibilities

  • Travel onsite for client, vendor, and other external partners to conduct audits and ensure regulations and guidelines are followed
  • Implement, oversee, manage, and train team members on QMS systems
  • Lead the development, execution, review and approval process of deviations, investigations, CAPAs, change request, SOPs and other various controlled documents
  • Perform batch record review, product release, validation, stability reports, inspections, and root cause analysis
  • Other responsibilities as assignedRequirements:
    • BS in Chemistry, Chemical Sciences, Biochemistry or equivalent education and experience
    • Minimum 5+ years of Quality Assurance biopharmaceutical experience in a GMP environment
    • Must have experience working with large molecules, gene therapy experience a plus...

Keywords: Hydrogen UK Ltd, Philadelphia , Quality Assurance Manager - GMP, Executive , Philadelphia, Pennsylvania

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