Senior Quality Assurance Specialist

1 week ago

Cork, Cork, Ireland beBeeQuality Full time €55,000 - €85,000
Key Quality Assurance Role

A key role in ensuring the quality and regulatory compliance of our products is required.

Job Description:

This professional will be part of a cross-functional team, implementing and upholding quality assurance standards.

Responsibilities:
  • Develop and Maintain Quality Procedures: Develop and maintain quality procedures, policies, and systems.
  • Conduct Routine Inspections: Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP and other relevant regulations.
  • Collaborate with Teams: Collaborate with teams to ensure quality throughout the manufacturing process.
  • Investigate Deviations: Investigate and address deviations, non-conformities, and CAPA to maintain quality.
  • Maintain Regulatory Compliance: Ensure compliance with periodic review, change control, deviation, backup, archive, security, and other support processes for systems.
The Ideal Candidate:
  • BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.
  • 3+ years of experience in quality assurance within a biotechnology, pharmaceutical, or medical device manufacturing environment.
  • Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management, and other biopharmaceutical regulatory requirements.
  • Excellent problem-solving and analytical skills.
  • Detail-oriented with a strong commitment to maintaining high-quality standards.
  • Effective communication and teamwork skills.

This is an exciting opportunity to contribute to our success, with a focus on quality and regulatory compliance.

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