Description
QA Regulatory Affairs Graduate
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
Based in our Kerry Plant and reporting to the QA Regulatory Affairs Co-Ordinator, the QA Regulatory Affairs Graduate will be responsible for assisting with the ongoing implementation and maintenance of regulatory documentation to ensure site compliance with regulatory CTDs.
They will also be required to respond to to internal and external regulatory queries, as well as the ensuring the maintenance of the First Lot to Stock system & maintenance of GMP documents such as Product Specifications, Batch Release Documents, Annual Reports, Manufacturing Authorisation and Site Master File.
Responsibilities
Maintenance of site regulatory and variation control:
Tracking of variation submissions and approvals.
Updating of internal documentation following variation approval.
Preparation of documents for Health Authority requests for renewals/variations e.g. Certificates of Pharmaceutical Product, stability tables, CoAs, GMP certificate.
Update of Manufacturers Authorisation.
Preparation of samples for variation and health authority requests.
QA Regulatory Affairs support for major projects within AICL (KP), including LEAN/ OPEX activities.
Participating in cross functional meetings for variations.
Document preparation:
Product specifications, Site Master File, batch release documents, SOPs and Work Instructions for QA Regulatory Affairs, Annual PQRs and Annual reports.
Organisation of notary and legalization for document requests.
Document preparation for product launches.
First lot to stock system tracking of batch information.
Essential Knowledge & Experience
Exceptional attention to detail and organisational skills.
Proficiency in Microsoft Office Suite, including MS Excel, Word and PowerPoint
Excellent communication and collaboration skills.
Ability to manage multiple tasks and deadlines effectively.
Education/Qualifications
Third level qualification in Science discipline, or equivalent.
Additional Information
This is a 2-year fixed-term contract starting on 1st September ****.
This position is on-site based in (Kerry plant Killorglin/Ireland).
Candidates must be located within a commutable distance of 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.