Pharmaceutical Quality Control Professional

1 week ago


Dublin, Dublin City, Ireland beBeeQuality Full time €60,000 - €75,000

Job Role:

Quality Assurance Specialist

We are seeking a seasoned Quality Assurance professional to join our team. As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality of our products and services.

Key Responsibilities:
  • Review and approval of Master Batch Records, Electronic Batch Records, and production documentation for accuracy and compliance with regulatory requirements.
  • Presence on the shop floor to support compliance and data integrity.
  • Review and approval of Standard Operating Procedures (SOPs) and Controlled Job Aides.
  • Participation in the Tier process to make issues visible and partner with functional areas on resolution.
  • QA support for Commissioning and Qualification lifecycle documents, Performance qualification activities, and sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification, and Periodic review.
Requirements:
  • Bachelor degree in a scientific or engineering field.
  • Minimum 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance, or Laboratory environment.
  • Experience in biotech industry with specific understanding of QA operations and Regulatory agency engagement.

Essential Skills:

  • Quality systems.
  • Pharmaceutical manufacturing or laboratory processes.
  • Authoring and approving regulated documents.


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