Quality Assurance Operations Coordinator
About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
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 work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
Based in our Kerry Plant, the QA Systems Coordinator will be responsible for supporting compliance with cGMP regulations, as well as the development and maintenance of the Quality Management System. The position is therefore responsible for coordinating the ongoing development, implementation, and maintenance of cGMP compliance. The role involves coordinating a team of QA Operations Specialists.
Key Responsibilities:
- Foster a culture of cGMP & Quality awareness across management and staff
- Ensure site-wide compliance with cGMPs, including data integrity.
- Coordinate line clearance activity to efficiently support manufacturing operations.
- Coordinate 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.
- Provide support were required for internal/external audits and regulatory/customer inspections.
- Coordinate the review and QA approval of SOPs/ controlled documents for QA, plant, warehouse, and QC; ensuring cGMP compliance.
- Support the Product Quality Review process through authoring and review stages.
- QA representative on major projects within AICL (KP), including LEAN/ OPEX activities.
- Other support areas include but are not limited to: team performance management, recruitment support, and coordination of training of new personnel.
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.
- Team lead/ supervisory or team activity lead experience.
- 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.
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