Senior Quality Assurance Manager

2 days ago

Dún Laoghaire, Dún Laoghaire-Rathdown, Ireland beBeeQuality Full time €120,000 - €150,000
Job Title: Quality Assurance Expert

This esteemed role involves acting as the primary Qualified Person (QP) on a manufacturing license. As a Quality Assurance Expert, you will provide scientific, quality, compliance, and patient-centered support to the manufacturing site.

  • Serving as the main QP for aseptically manufactured, parenteral products
  • Offering advice, guidance, and support to Amgen QPs and other functions based on past experiences and knowledge
  • Coaching and mentoring quality colleagues to develop problem-solving, decision-making, and critical-thinking skills
About This Role
  • Evaluating multiple data sources and perspectives to accurately characterize problems and opportunities; solving complex problems with little precedent
  • Aligning views and reaching decisions by bringing together stakeholders with divergent views
  • Contributing to Product Quality Technical Agreements within the Quality Department as needed
  • Supporting inspection readiness, including developing playbooks and reviewing responses to GMP inspections
Requirements:
  • Highly organized with good time management and prioritization skills
  • Critical thinking and evaluation of process problems
  • Excellent verbal and written communication skills, with the ability to communicate with a diverse audience
  • Patient and results-focused
  • Good leadership skills and highly motivated
  • Collaborative team player
  • Strong work ethic with a flexible and adaptable approach
  • Thorough understanding of Quality Systems and cGMPs
  • Interpersonal and professional skills to interact at all levels, including senior executives, contractors, and colleagues
Key Responsibilities:
  • Conducting vendor audits and site visits as required
  • Overseeing the evaluation of quality and distribution complaints
  • Leading projects and improvement efforts, including product launches

As a Quality Assurance Expert, you will have the opportunity to make a significant impact on our organization's success while growing your skills and expertise in a dynamic environment.

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