QA Systems Specialist

Astellas; Ireland; Hybrid; EUR 40,000 - 55,000; Full time

Job summary

Astellas is seeking a QA professional to support cGxP compliance at its Killorglin, Kerry facility. The six-month FTC involves quality systems, audits, and product quality reviews. You will review eQMS records, coordinate internal and external audits, and drive continuous improvement through lean initiatives.

A background in pharmaceutical quality, cGMP, and good documentation practices is preferred. This hybrid role offers collaboration across QA teams and external partners, contributing to

Qualifications

• BSc or equivalent academic qualification required.
• Industrial/pharmaceutical experience preferred.
• Familiarity with cGMP, audits and eQMS workflows.
• Knowledge of GxP and regulatory submissions.

Responsibilities

• QA review & approval of eQMS records and related documents.
• Support TrackWise metrics and QMS progression with stakeholders.
• Coordinate internal and external audits and ensure CAPA follow-up.
• Assist in regulatory updates and GMP trends.
• Contribute to Product Quality Reviews and LEAN initiatives.

Skills

cGMP

Auditing

Customer complaint investigations

eQMS support

Good Documentation Practices

5S

Regulatory updates

Education

BSc or equivalent

Job description

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com .

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Working Environment and Location

• This position is Hybrid from the Killorglin, County Kerry facility.

Working Hours

• This position is a 6 month FTC.

Purpose and Scope

Responsible for supporting the on-going development, implementation and maintenance of cGxP compliance.

Role and Responsibilities

Working in Systems

eQMS

• QA review & approval of eQMS records. Ensure that eQMS records are appropriately investigated and progressed in accordance with eQMS procedures.
• Support on-time eQMS progression working with all stakeholders. Issuance of TrackWise metrics monthly and trending on an on-going basis to support QMS management.

Vault Quality

• Performs QA review and approval of, change requests and proposed revised/new standard operating procedures, test methods etc. to ensure that they are accurate, complete and compliant with the process and cGxP.

Customer Complaints/Product Security Incidents & Recalls

• Ensures that customer complaints are investigated in an efficient and effective manner.
• Co-ordinates site wide investigations into complaints, prepares final report.
• Conducts investigations into any potential security incident and liaise with relevant personnel in the Astellas network.
• Conducts periodic evaluation of the recall procedure.

Internal Audits

• Ensures efficient and effective cGxP auditing of AICL (KP)’s quality system.
• Prepares for an audit by performing a thorough review of cGxP regulations, GMP trends, guidance documents etc.
• Conducts the audit by reviewing the process, documentation and procedures.
• Reports the audit findings to Management.
• Follows up on audits to ensure that appropriate corrective actions have been implemented where necessary.

External Audits

• Prepares, conducts, reports and follows up on audits of key vendors and contract analysis agents to AICL in order to assess their compliance with quality/ technical agreements and cGMP.
• Assists in the preparation and overall support for external audits of AICL (including regulatory, corporate and customer audits).

Regulatory updates and GMP Trends

• Review changes in Regulatory Updates and GMP trends as assess AICL (KP) compliance.

Product Quality Reviews

• Coordinate report preparation and approval for Product Quality Reviews. Support related eQMS workflow progressions.

LEAN Initiatives

• Lead or participate in lean and continuous improvement initiatives as required.

Project Work

• Quality representative on major projects within AICL (KP).
• Ensures compliance with cGMP and regulatory submissions.

Essential Qualifications

• BSc or equivalent academic qualifications.

Preferred Qualifications

• Industrial/pharmaceutical experience would be an advantage.
• cGMP, Auditing, Customer Complaint Investigations, eQMS records support and related workflows, Safety, Good Documentation Practices, 5S.

Benefits

Careers | Astellas

Why Astellas

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organisational Values and Behaviours

Integrity Innovation Impact One Astellas Accountability Courage Sense of Urgency Outcome Focus

Organizational Focus

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.