Description
Quality Assurance Operations Specialist
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 at our Kerry Plant, you will take on the role of QA Operations Specialist, where you'll be responsible for ensuring compliance with cGMP regulations and supporting the development and maintenance of our Quality Management System. In this position, you'll play a key role in the ongoing development, implementation, and upkeep of cGMP compliance. You'll work closely with a team of fellow QA Operations Specialists to achieve these goals.
Key Responsibilities
* Foster a culture of cGMP & Quality awareness across management and staff.
* Ensure site-wide compliance with cGMPs, including data integrity.
* Perform line clearance activity to efficiently support manufacturing operations.
* Support QA batch record reviews to proactively meet product value stream schedules.
* Ensure inspection readiness through timely and compliant progression of eQMS records.
* Provide real-time support for manufacturing, QC, and operations: including non-conformance management, root cause investigations, risk assessments, CAPA and effectiveness checks.
* QA representative on major projects within AICL (KP), including LEAN/ OPEX activities.
Education
* Third level qualification in Science or Engineering discipline, preferably with experience of working in a GMP environment or equivalent.
Preferred Knowledge/ Skills & Experience
* Knowledge of regulatory requirements related to pharmaceutical manufacture.
* Exceptional attention to detail and organisational skills.
* Proficiency in Microsoft Office Suite, including MS Excel.
* Excellent communication and collaboration skills.
* Ability to manage multiple tasks and deadlines effectively.
What We Offer
* A challenging and diversified job in a parenteral and oral dosage finished pharmaceutical manufacturing facility.
* Opportunity and support for continuous development.
* Inspiring work climate.
Additional Information
* This is a specific purpose contract.
* Position is based on-site in Killorglin, Co. Kerry.
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.