Senior Quality Professional
2 weeks ago
Job Summary:
This position serves as the primary Qualified Person (QP) on the manufacturing license for aseptically manufactured, parenteral products. The QP acts as the main point of contact for quality and compliance matters, providing scientific support to the Amgen manufacturing site.
Key Responsibilities:
- Serve as the primary QP at ATI for aseptically manufactured, parenteral products
- Offer advice and guidance to Amgen QPs and other functions based on past experiences and knowledge
- Coach and mentor quality colleagues to develop problem-solving skills
- Evaluate multiple data sources and perspectives to accurately characterize problems and opportunities
- Align views and reach decisions by bringing together stakeholders with divergent views
- Support inspection readiness, including developing playbooks and reviewing responses to GMP inspections
- Provide technical support for successful outcomes of all regulatory inspections
- Conduct vendor audits and site visits as required
- Oversee the evaluation of quality and distribution complaints
- Lead projects and improvement efforts, including product launches
Requirements:
- Highly organized with good time management and prioritization skills
- Critical thinking and evaluation of process problems
- Excellent verbal and written communication skills
- 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
Education & Knowledge:
- University Degree in Pharmacy
- OR University Degree in a Science related discipline together with a post graduate course satisfying educational requirements
- Knowledge of manufacturing processes, warehousing, supply chain, equipment engineering principles, and validation
Experience:
- Relevant experience working in the pharmaceutical or Biotechnology Industry over a minimum of 10 years
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