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Quality Control Manager

3 weeks ago

Limerick, Limerick, Ireland beBee Careers Full time
Job Description:

This Senior Quality Engineer will play a critical role in maintaining the quality and regulatory compliance of biopharmaceutical products within a next-generation manufacturing facility. The ideal candidate will have strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management, and other biopharmaceutical regulatory requirements. They will work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.

Main Responsibilities:
  • Maintain accurate and comprehensive quality records, including procedures, qualification documentation, change control documentation, and quality reports.
  • Prepare and review documentation related to product quality and compliance, including GMP standard operating procedures and process flow documents.
  • Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes.
  • Provide training to staff on quality-related procedures and best practices.