Description
Quality Assurance Validation is a critical function within the Astellas Ireland Co. Ltd. Tralee Plant Aseptic Manufacturing Facility.
Astellas is a global pharmaceutical company with a strong commitment to quality and patient centricity. Our culture is built on five core values: patient focus, ownership, results, openness, and integrity.
The QA Validation resource will be primarily responsible for ensuring adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures.
This role works closely with Validation, Engineering, Manufacturing, Facilities, Document/Data Management, Quality Control (QC), and other GxP supporting functions to ensure compliance.
Responsibilities:
* Build strong relationships and collaboration between the Plant QA team and stakeholders.
* Provide hands-on QA support to staff, suppliers, and contractors.
* Review and approve commissioning and qualification documents.
* Partner with the Validation team to define strategies and support the implementation of validation projects.
* Author, review, and approve controlled documents.
* Participate in audits, manage Change Control systems, and support deviation investigations.
Requirements:
* Proficient in regional Good Manufacturing Practices (GMP) for pharmaceutical products.
* Knowledgeable in technology used for manufacturing and testing biological products.
* Experienced in pharmaceutical quality management systems (QMS).
Education:
* Science-based degree with experience in a cGMP compliance environment.