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.
Location and Working Environment
This position is based in the Kerry (Killorglin) Plant and will require onsite working.
Working Hours
Full time
Purpose and Scope
Based in our Kerry Plant (Killorglin) and reporting to the QA Systems Co-Ordinator, the QA Specialist will primarily be responsible for supporting the issuance and control of production batch records, ensuring compliance with GMP requirements and site procedures. The position will also be responsible for supporting compliance with cGMP regulations, as well as the development and maintenance of the Quality Management System. The position is therefore responsible for assisting with the ongoing development, implementation, and maintenance of cGMP compliance.
Role and Responsibilities
Primary Responsibilities:
- Support the issuance and control of production batch records in accordance with GMP and site procedures.
- Act as a key point of contact, liaising closely with Production and Quality Assurance personnel to ensure batch record and documentation requests are completed accurately and on time.
- Ensuring data integrity and compliance with regulatory requirements.
Secondary Responsibilities:
- Foster a culture of cGMP & Quality awareness across management and staff.
- Ensure site-wide compliance with cGMPs, including data integrity.
- Support inspection readiness through timely and compliant progression of eQMS records.
- Provide real-time support for manufacturing, QC, and operations: including non-conformance management, root cause investigations, risk assessments, CAPA and effectiveness checks.
- Assist with internal/external audits and regulatory/customer inspections.
- Coordinate the customer complaints process, including investigation progression and final reports.
- Support supplier qualification process and related risk management.
- Review and QA approve SOPs/ controlled documents for QA, plant, warehouse, and QC; ensuring cGMP compliance.
- Compilation of inspection readiness metrics.
- Support the Product Quality Review process.
- QA representative on major projects within AICL (KP), including LEAN/ OPEX activities.
- Other support areas include but are not limited to: quality investigations, TrackWise, ADMS authoring, training of new personnel and batch review activity, as assigned.
Required Qualifications
- Third level qualification in Science or Engineering discipline, preferably with experience of working in a GMP environment or equivalent.
Preferred Qualifications
- Excellent communication and collaboration skills.
- Knowledge of regulatory requirements related to pharmaceutical manufacture.
- Exceptional attention to detail and organisational skills.
- Proficiency in Microsoft Office Suite, including MS Excel.
- Ability to manage multiple tasks and deadlines effectively.
What awaits you at Astellas?
- Global collaboration: Work within a connected global community dedicated to improving patient lives.
- Real world patient impact: Contribute to life changing therapies that help people worldwide.
- Relentless innovation: Be part of an organisation pushing scientific and operational boundaries.
- A Culture of Growth: Thrive in a supportive workplace that values development and progression.
Our Organisational Values and Behaviours
- Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
Benefits
Careers | 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.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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