Operational Shift Manager

20 hours ago


Dublin, Dublin City, Ireland beBeeOperations Full time
Job Title: Operations Shift Coordinator

We are seeking a highly skilled Operations Shift Coordinator to join our team. As a key member of our operations team, you will be responsible for ensuring the smooth operation of our production process.

  • Key Responsibilities:
    • Review and approve Master Batch Records / Electronic Batch Records
    • Review and approve production documentation to ensure accuracy and compliance with cGMPs and company procedures
    • Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aides
    • QA support, review, and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment

Requirements:

  • Extensive relevant post-degree work experience in GMP Manufacturing, Quality Assurance or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations
  • At least 5 years of working knowledge in the biotech industry, with a specific understanding of QA operations an advantage as well as Regulatory agency engagement
  • Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
  • Quality systems, pharmaceutical manufacturing, or laboratory processes, authoring and approving GMP documents

Benefits:

  • Opportunity to work on exciting pharmaceutical projects
  • Collaborative and dynamic work environment
  • Professional development and growth opportunities

Other Information:

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