QA Senior Associate

3 days ago

Dublin, Dublin City, Ireland beBeeQuality Full time €72,920 - €99,105

Life Science Consultants are seeking a skilled QA Senior Associate to fill key roles. This is an exciting opportunity for experienced professionals to contribute their expertise in quality assurance and regulatory compliance.

Key Responsibilities
  • Review and approve production batch records and associated documentation for Qualified Person disposition activities, ensuring accuracy and consistency.
  • Provide real-time quality oversight and support for production unit operations, extending to formulation, vial and syringe Fill Finish activities, promoting efficiency and effectiveness.
  • Offer Quality Assurance support for on-the-floor investigations and deviations, utilizing problem-solving skills and analytical thinking.
  • Review and approve deviations for closure, ensuring compliance with appropriate documentation and regulatory requirements.
  • Participate in customer complaint investigations, analyzing issues and providing recommendations for improvement.
  • Conduct routine Quality Assurance walks on the production floor, monitoring processes and identifying areas for enhancement.
About You
  • A university degree in Engineering or Science related discipline is preferred, but not required.
  • Four years of experience in construction management/engineering within the pharmaceutical or biotechnology industry is necessary, demonstrating expertise and knowledge.
  • Exceptional written and verbal communication skills are essential, enabling effective collaboration and clear expression of ideas.
  • Proven experience collaborating with dynamic cross-functional teams and strong decision-making abilities are critical, supporting informed decisions and successful outcomes.
  • Demonstrated problem-solving abilities, particularly in supporting non-conformance/deviation investigations, are valuable assets.
  • Experience in inspecting vials and syringes and engaging in aseptic operations is highly desirable, showcasing specialized skills and attention to detail.
  • Familiarity with applicable Regulatory requirements and proficiency in evaluating compliance issues is essential, ensuring adherence to regulations and standards.

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