Drug Substance Production Manager

6 days ago

Dundalk, Louth, Ireland beBeeManufacturing Full time €120,000 - €150,000
Quality Assurance Lead for Biologic Drug Substance Manufacturing

This is a pivotal position within the quality assurance organisation, responsible for ensuring that biologic drug substance manufacturing processes are performed in accordance with cGMP, site standard operating procedures (SOPs) and controlled documents from end-to-end.

About the Role:

The role requires leading the quality assurance team responsible for 24/7 oversight of warehouse and supply chain management, drug substance manufacturing operations and the quality assurance team responsible for batch disposition operations.

  • Key Responsibilities:
  • Lead the QA team responsible for 24/7 oversight of Warehouse and Supply Chain Management (SCM), Drug Substance Manufacturing Operations and the QA team responsible for batch disposition operations.
  • Develop, implement, and monitor quality systems relating to warehouse, SCM and manufacturing and batch disposition operations.
  • Provide QA review and approval of SOPs, master batch records, quality risk assessments, change controls and other documentation associated with Manufacturing, Warehouse, SCM and batch disposition operations.
  • Review and approve deviation reports, CAPAs, and technical documents to support GMP decisions and batch disposition.
Requirements:
  • 8+ years experience in the biotechnology and/or pharmaceutical industries within a Quality role, preferably in QA or similar.
  • Demonstrated knowledge of Quality Management System and continuous/process improvement tools.
  • Strong technical aptitude and problem-solving skills, including knowledge of trouble shooting and root cause analysis.
  • Excellent interpersonal and communication skills, as well as organisational and adaptability skills.
What We Offer:
  • Competitive salary and bonus scheme.
  • Extensive range of benefits, including educational assistance, life assurance, parking and pension.

Our company values diversity and inclusivity in the workplace. We welcome applications from all qualified candidates.

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