Primary Qualified Person
About Astellas
At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges, placing the patient at the heart of everything we do. Through our global vision for Patient Centricity, we integrate the patient experience into our everyday working practices. We have developed ground breaking medicines in immunology, oncology and urology, improving and saving the lives of patients worldwide. Learn more about Astellas.com
Are you driven to make a real difference in the lives of patients?
We are seeking individuals who thrive in dynamic environments, embrace new ideas and are committed to making a meaningful impact.
Location and Working Environment
This position is 100% onsite in Tralee, Ireland.
Purpose & Scope
- The Primary Qualified Person is responsible for the batch release of drug product. Additional responsibilities include the development, implementation, maintenance and control of critical quality systems.
- This involves control of such items such as appropriate review of batch documentation/ data, development of Quality Assurance procedures, investigation of stability issues, review of all quality related changes including non-conformances, alerts and change controls, oversight of post-batch release related events, i.e. customer complaints, product security/suspected counterfeit and review of trending programmes and reporting of non-conformances from guidelines etc.
Role and Responsibilities
- Batch Release & Compliance: Certify and release batches in line with Article 47 of Directive 2001/83/EC, Annex 16, cGMP, and Manufacturing Authorisation requirements, ensuring all manufacturing and QC checks are complete and compliant.
- Documentation & Quality Oversight: Review and approve batch-related documentation (e.g., deviations, OOS/OOT, change controls, supplier/contractor records), Product Quality Reviews (PQRs), MBRs, and processing instructions.
- Investigation & Risk Management: Oversee investigations into OOS, OOT, and major/critical non-conformances, ensure GMP-compliant documentation, and support risk identification and mitigation.
- Quality Systems & Governance: Participate in management and Quality System Reviews, monitor CAPA status, approve Quality Agreements, and ensure effective systems for returned goods disposition.
- Regulatory & External Engagement: Liaise with regulatory authorities, contract manufacturers, industry groups, and global QA peers; maintain awareness of evolving regulatory requirements and support implementation.
- Leadership & Operational Support: Contribute to management forums and major projects, coach QA team members, support local problem-solving, and promote a strong quality-focused culture across the site.
Required Qualifications
- Science based degree with extensive experience in a cGMP compliance environment. Extensive experience with supporting Lyophilisation and all aspects of Aseptic Manufacturing. QP eligibility is required.
What awaits you at Astellas?
- Global collaboration and connection with like minded life science leaders.
- Real world patient impact through transformative therapies.
- Relentless innovation at the forefront of scientific advancement.
- A culture of growth that supports your development and ambitions.
Our Organizational Values and Behaviors
- Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
Benefits
Career | Astellas
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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