Quality Assurance Validation

1w1 week ago

Astellas Pharma

IE · Full-time · €60,000 – €80,000

About this role

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. It provides transformative therapies in oncology, ophthalmology, urology, immunology, and women's health. The Quality Assurance Validation role supports compliant GMP operations at the Tralee Plant Aseptic Manufacturing Facility.

The role implements, executes, and assesses quality systems, procedures, and records. It ensures adherence to agency regulations (GxP), industry best practices, local regulations, and internal policies. Responsibilities include direct collaboration and oversight of validation activities.

This position works closely with Validation, Engineering, Manufacturing, Facilities, QC, and other GxP functions. It provides hands-on QA oversight to staff and contractors for compliance with SOPs and GxP standards. Strong cross-functional relationships ensure clear quality requirements from project start.

Review and approve validation lifecycle documentation including plans, protocols, reports, deviations, and change controls. Partner with stakeholders to define strategies and achieve timely facility readiness in cGMP environments. Thrive in dynamic settings to make a meaningful impact for patients.

Requirements

Knowledge of GxP regulations and GMP operations in aseptic manufacturing
Experience reviewing and approving validation lifecycle documentation
Familiarity with SOPs, quality systems, and procedures in pharmaceutical environments
Ability to provide QA oversight for validation, engineering, and manufacturing activities
Understanding of risk assessments, protocols, deviations, and change controls
Cross-functional collaboration skills with QC, facilities, and GxP supporting functions
Proficiency in auditing data and reports per standard operating procedures

Responsibilities

Build strong cross-functional relationships to ensure clear quality requirements and effective collaboration from project start
Provide hands-on QA oversight to staff and contractors, ensuring compliance with SOPs and GxP standards
Review and approve validation lifecycle documentation (plans, specifications, risk assessments, protocols, reports, deviations, and change controls)
Partner with validation and stakeholders to define strategies, support project execution, and ensure timely, high-quality facility readiness in a cGMP environment
Implement, execute, and assess quality systems, procedures, and records to support compliant GMP operations
Ensure adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies
Oversee Validation, Facilities/Engineering, Manufacturing Operations, and QC activities through review/audit of data and reports