Job Overview
As the Associate Director QA, you will play a pivotal role in ensuring the quality and compliance of our products at the Amgen Technology Ireland manufacturing site. Your primary responsibility will be to act as the main Qualified Person (QP) on the ATI manufacturing license.
Main Responsibilities
1. Serving as the primary QP at ATI for aseptically manufactured, parenteral products.
2. Offering advice, guidance, and support to Amgen Quality teams based on past experiences and knowledge.
3. Clinical trials for investigational medicinal products manufactured in the EU or third countries, including ensuring compliance with laws and regulations.
4. Maintaining close contact and familiarity with Amgen Quality systems and programs used at other Amgen sites.
5. Acting as the primary liaison to HPRA.
Required Skills and Qualifications
* 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 diverse audiences.
* 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.
* Relevant experience working in the pharmaceutical or Biotechnology Industry over a minimum of 10 years.
Benefits and Opportunities
* University Degree in Pharmacy OR University Degree in a Science related discipline together with a post graduate course.
* Knowledge of the processes involved in manufacturing (GMP), warehousing, supply chain, equipment engineering principles and validation.
* Knowledge of applicable regulatory requirements.
Location
* Dublin, IE.