About Astellas:
At Astellas we are making treatments that matter to people.
We are tackling the toughest health challenges putting the patient at the heart of every move we make.
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 have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.
We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives.
From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.
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.
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.
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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