Senior Biopharmaceutical Quality Assurance Specialist

2 weeks ago

Cork, Cork, Ireland beBeeQuality Full time €60,000 - €80,000

Biopharmaceutical Quality Assurance Professional

We are seeking a highly skilled Biopharmaceutical Quality Assurance Professional to join our team. This role will be based in a state-of-the-art manufacturing facility and will play a critical role in maintaining quality and regulatory compliance of biopharmaceutical products.

Key Responsibilities:

  • Develop and maintain quality assurance procedures, policies, and systems.
  • Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP and other relevant regulations.

Collaboration and Support:

  • Collaborate with automation, IT, and production teams to ensure quality throughout the manufacturing process.
  • Investigate and address deviations, non-conformities, and CAPA to maintain quality.

The Ideal Candidate:

We are looking for a candidate with a BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline. At least 3 years of experience in quality assurance within a biotechnology, pharmaceutical, or medical device manufacturing environment is required. Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management, and other biopharmaceutical regulatory requirements is also essential.

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