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Quality Assurance Specialist

3 weeks ago

Dublin, Dublin City, Ireland Next Generation Recruitment Full time

Job Description:

  • We are seeking a highly motivated and experienced Quality Specialist to join our team in ensuring the quality and compliance of manufactured products.
  • The Quality Specialist will provide direct Quality support to a production area as part of an Integrated Product Team (IPT).
  • This role ensures adherence to Good Manufacturing and Documentation Practices, and represents quality on the shop floor.
  • The Quality Specialist reviews process documentation and data for accuracy, completeness, and compliance with data integrity standards.
  • This individual may also support batch disposition activities, assist in deviation investigations, and spend significant time on the shop floor, providing quality coaching and guidance.
  • Key Responsibilities:
    • Review and approve new and updated Master Batch Records / Electronic Batch Records.
    • Ensure accuracy and compliance by reviewing and approving production documentation such as executed electronic batch records and logbooks.
    • Provide quality presence on the shop floor to support compliance and data integrity.
    • Review and approve new and updated SOPs, Work Instructions, and Controlled Job Aides.
    • Actively participate in Tier processes to surface and resolve quality issues.
    • Provide QA support for commissioning and qualification lifecycle documents for capital projects and new equipment.
  • Experience & Qualifications:
    • Minimum 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance, or Laboratory environments within the pharmaceutical or biotech industry.
    • Expertise in Quality Assurance operations and Regulatory agency engagement.
    • Strong leadership, oral, and written communication skills.
    • Deep understanding of cGMPs and regulatory requirements.
    • Excellent interpersonal skills, with the ability to collaborate in a team environment.
    • Bachelor's degree in a scientific or engineering field.