Astellas is making treatments that matter to people.
Our Vision
We are tackling the toughest health challenges by 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.
A Patient-Centric Culture
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 take a patient-focused approach, empowering the best talent to pursue the most promising science and develop life-changing solutions alongside the best partners.
From lab to clinic to patient, we focus on extending and saving lives, improving quality of life, and converting brilliant early science into treatments and solutions that directly improve patients' lives.
The Opportunity
You will be reporting to the Quality Assurance Manager and will be required to work with Quality Assurance and other staff to foster an ethos and culture of c GMP & Quality awareness.
Your Responsibilities
* Foster a culture of c GMP & Quality awareness across management and staff.
* Ensure site-wide compliance with c GMPs, including data integrity.
* Provide real-time support for manufacturing, QC, and operations, including batch record review, deviation management, CAPA, and change management.
* Support warehouse operations with finished product labelling, shipping checks, and temperature mapping.
* Assist with internal/external audits and regulatory/customer inspections.
* Review and approve QA SOPs, plant, warehouse, and QC procedures, ensuring compliance with ISO 14001, Health & Safety, and Environmental regulations.
Requirements
* Knowledge of regulatory requirements related to pharmaceutical manufacture.
* Able to work effectively using own initiative, have good organizational skills.
* Strong verbal and written communication skills.
* Third level qualification in Science or Engineering discipline, preferably with experience of working in a GMP environment or equivalent.
What We Offer
A challenging and diversified job in an international setting.
Opportunity and support for continuous development.
Inspiring work climate.
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.