About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
This opportunity is located in Ireland (Tralee).
The opportunity:
As a Training Specialist, your role will be to support the operations department in identifying and ensuring team training compliance with GMP/GDP requirements for an Aseptic fill finish facility. You will be responsible for ensuring that the team is adequately trained to adhere to regulations, guidance, industry best practices, and internal policies and procedures. In this position, you will work closely with operations functions, particularly the Learning and Development department, to ensure ongoing compliance.
Key Responsibilities:
- Department Operation:
- Identify and implement plans to develop experts in GDP and Aseptic Operations, continuously enhancing training activities.
- Assess and address training needs for employees, working with internal and external providers to meet current and future business needs.
- Prepare customized training materials (e.g., programs, curricula, e-learning modules) based on role and level.
- Ensure compliance with regulatory, legislative, and statutory requirements, promoting quality and safety awareness.
- Develop operational procedures to maintain best practices and regulatory compliance.
- Generate reports and track training data, ensuring all training records are traceable and available for audits.
- Projects & Support:
- Provide training support for plant initiatives, including Commissioning/Qualification activities.
- Reporting:
- Regularly report to the Operations Lead and address potential issues like resource gaps or training concerns.
- Attend meetings as required and provide feedback when necessary.
Essential Knowledge & Experience:
- Experience in a GMP pharmaceutical manufacturing environment, with proven skills in on-the-job training, instructional design, and curriculum development.
- Strong interpersonal, communication, organizational, and planning skills, with the ability to work proactively and independently.
- Experience with audits, regulatory guidance, Aseptic Fill finish operations, and a flexible, solutions-focused approach to continuous improvement.
Education:
- Third level qualification in an Engineering or Science discipline, or extensive related proven experience in the required areas.
Additional information:
• This is a permanent full-time position
• Position is based in Tralee – Ireland
• This position requires you to be 100% on site / in the office
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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