Quality Assurance Operations
Core
Ensure compliance of all manufacturing activities at the Astellas Ireland Tralee Plant with cGMP regulations and facilitate regulatory inspections.
Role type
Quality Assurance Operations Manager (Pharmaceutical Manufacturing)
Builds
Robust QA processes, batch record reviews, and quality management systems for aseptic manufacturing.
Domain
Life Sciences / Pharmaceutical Manufacturing / cGMP
Required skills
cGMP compliance, aseptic manufacturing knowledge, regulatory inspection support, batch record review, quality management systems, stakeholder collaboration, audit facilitation, mentorship
Preferred skills
QP Eligibility
Technologies
GMP training systems, Quality Management Systems
Responsibilities
Establish and maintain QA processes and batch record review; Provide QA oversight across manufacturing, warehousing, and facilities; Support regulatory and customer audits; Champion Quality and Compliance culture across the plant.
