• Quality Assurance Specialist Ireland
  • Astellas in Ireland, , Ireland
  • jobs
  • 1 month ago

jobs description

Algemene informatie


Quality Assurance Specialist



Functie/Business Area



Quality Assurance Operations


Arbeidsovereenkomst voor bepaalde tijd


Quality Assurance Specialist

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.

Reporting to the QA Coordinator, the Quality Assurance Specialist will be responsible for the ongoing development, implementation, and maintenance of company compliance with GMP regulations. The chosen candidate will also be involved in the development of regulatory system/standards.

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

Executing line... clearance checks in accordance with approved procedures and GMP requirements. Assessing and reporting any critical or non-critical line clearance incidents Performing thorough and prompt quality reviews of batch records to ensure all batches are suitable for release by the QP. Highlighting batch records errors to Production Participating in SDI meetings Ensuring effective investigation and assessment of quality issues and productivity initiatives associated with Production and Engineering Liaising with departments to prevent quality issues arising. Coaching and advising line operation personnel on compliance requirements and best practice Ensuring that cleaning validation is conducted as per schedule. Preparing and maintaining weekly shipping schedule Ensuring efficient and effective auditing of AICL (KP)’s quality system Supporting audit preparation through thorough review of cGMP regulations, GMP trends, guidance documents etc Conducting audits through review of process, documentation, and procedures, and reporting audit findings to management Following up on audits to ensure that appropriate corrective actions have been implemented as necessary. Preparing, conducting, reporting, and following up on audits of key vendors and contract analysis agents to AICL in order to assess their compliance with technical agreements and cGMP. Assisting in preparation for external audits of AICL (including regulatory, corporate and customer audits) Ensuring customer complaints are investigated in an efficient and effective manner by coordinating site wide investigations and preparing final reports. Conducting investigations into any potential security incidents and liaising with relevant personnel in the Astellas network Conducting periodic evaluation of the recall procedure Performing regular housekeeping inspections in Production, Laboratories and Warehouse in order to ensure continued compliance with cGMP. Various other tasks as directed by the QA Coordinator or QA Manager

Essential Knowledge & Experience BSc or equivalent academic qualifications essential Industrial/pharmaceutical experience highly advantageous Experience of cGMP, auditing, customer complaint investigations, batch record review, line clearances, GDP and 5S Good interpersonal and communication skills with ability to use initiative. Must be a team player with experience of working with cross functional teams.

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


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