Building your career at Astellas continues to offer inspiring challenges and a chance to make your mark in doing good for others.
Our open and progressive culture is what makes us Astellas. It is a culture of doing good for others and contributing to a sustainable society.
Based in our Kerry Plant and reporting to Lead Pharma Manu Engineering Tech KP, this role will be responsible for managing our Validation Document Storage, coordinating document workflows, assisting departments with periodic reviews, and performing various administrative functions. We are seeking a highly organised and detail-oriented Engineering Administrator for Document and Validation Control to join our team.
Join us in this dynamic role and contribute to our team's success at Astellas. Apply now to be part of this exciting journey.
About This Job
Validation Document Storage and Filing
- Organise and categorise documents into Process, Equipment, Lab, IT/General, and Quality categories.
- Log and index every incoming document, ensuring all entries are complete and accurate.
- Update document log approvals and revisions, maintaining version control and document indexing.
- File associated documents (e.g., PCRs with OQs) and handle SID forms based on CS number requirements.
Collaboration with Site Teams and Crown Users
- Coordinate with Crown users on-site for deliveries, returns, and document storage.
- Maintain communication for new box deliveries or updates to ensure seamless operations.
- Support departments with periodic document reviews by providing document revision status and approval dates.
Purchase Orders and Invoice Management
- Generate purchase orders and process invoices through SAP, ensuring accuracy and adherence to procedures.
- Communicate with requesters and verify approval before invoice processing.
- Maintain records of Capex budgets and fixed asset requests.
Document Control and Vault Management
- Review and manage validation documents on Veeva Vault, approving or rejecting as needed.
- Monitor and update CSV inventory in Vault, tracking any decommissioned items.
- Support the ValGenesis - VLMS system for routing and approving validation documents, completing access requests, managing user profiles, and running reports.
Supportive Administration and Group Coordination
- Handle access requests, hardware requests, and general administrative duties for the PTG team.
- Manage the PTG distribution list, stationary press, and group stationary budget.
- Arrange vendor accommodations and transportation, organising all necessary logistics.
Essential Knowledge & Experience
- Strong experience with document management, validation filing, and tracking systems (e.g., SAP, Veeva Vault, Trackwise EQMS).
- Exceptional attention to detail and organisational skills.
- Proficiency in Microsoft Office Suite, with advanced Excel skills.
- Excellent communication and collaboration skills.
- Ability to manage multiple tasks and deadlines effectively.
Preferred Qualifications:
- Previous experience in a quality or compliance role within a regulated industry (e.g., pharmaceuticals, medical devices).
- Knowledge of validation document processes (IQ, OQ, PQ).
- Familiarity with ValGenesis VLMS and Trackwise EQMS.
At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
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.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
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.