Shift Operations Professional

1 day ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time
Job Title: Operations Shift Specialist

This position involves working in a pharmaceutical centre of excellence, responsible for the development and production of veterinary vaccines.

Key Responsibilities:
  • Review and Approval: Responsible for reviewing and approving new and updated Master Batch Records/Electronic Batch Records to ensure accuracy and compliance with cGMPs and company procedures.
  • Production Documentation: Review and approve production documentation such as executed electronic batch records and logbooks to guarantee accuracy and adherence to regulatory requirements.
  • SOPs/Work Instructions: Review and approve new and updated SOPs/Work Instructions and Controlled Job Aides to maintain consistency and compliance within the organization.
  • QA Support: Provide QA support, review, and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
Requirements:
  • Experience: Requires extensive 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.
  • Candidate Profile: This role requires a seasoned professional with expertise in 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.
  • Skills: 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.
About Us:

We are a global leader in the development and production of veterinary vaccines. Our centre of excellence employs over 1000 people and is known for its commitment to quality and innovation.

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