Quality Assurance Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeQuality Full time €85,000 - €113,000
Job Title: Quality Assurance Specialist

The company is seeking a highly skilled Quality Assurance Specialist to join its team. This individual will be responsible for ensuring the quality and compliance of products manufactured by the functional area, adherence to good manufacturing and documentation practices, and representing quality on the shop floor.

This role requires strong analytical and problem-solving skills, with the ability to review and approve new and updated master batch records/electronic batch records, production documentation, and SOPs/work instructions. The successful candidate will also have excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.

Main Responsibilities:

  • Review and approval of new and updated master batch records/electronic batch records, production documentation, and SOPs/work instructions
  • Ensure accuracy and compliance with cGMPs and company procedures
  • Represent quality on the shop floor and provide direct quality support to a production area as part of a quality integrated product team (IPT)
  • Participate in the tier process and use this forum to make issues visible and partner with the functional area on resolution
  • QA support, review, and approval of commissioning and qualification lifecycle documents for capital projects and new equipment
  • Serve as the quality SME for performance qualification activities across the site, including but not limited to: equipment, facility, and utility PQ studies, cleaning validation, SIP, and process validation
  • Collaborate with cross-functional team members to identify and implement continuous improvement initiatives and action plans

Requirements:

  • Bachelor's degree in a scientific or engineering field
  • Minimum 5 years of 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
  • Seasoned professional with expertise and at least 5 years working knowledge in the biotech industry, with specific understanding of QA operations and engagement with regulatory agencies an advantage

About Us:

We are a leading multinational pharmaceutical organization that prioritizes quality and excellence. We offer a dynamic and supportive work environment, with opportunities for professional growth and development.

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