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About Astellas
At Astellas we are making treatments that matter to people.
Description
QC Chemist
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
Your main functions in this position will be to analyze active raw materials, in-process, and finished products in accordance with cGMP, GLP, and safety standards.
Key Responsibilities
* Perform analysis of in-process, raw material, final product, and stability samples, ensuring compliance with cGMP and regulatory requirements, and document/report results accurately.
* Conduct independent data reviews and ensure timely, accurate reporting in accordance with cGMP and regulatory standards.
* Handle sampling of raw materials and process/purified water, and manage qualification, calibration, and maintenance of QC instrumentation.
* Troubleshoot instrument issues, implement solutions, and contribute to root cause analysis and CAPA actions to improve laboratory RFT and testing processes.
* Develop and revise procedures, execute instrument and method validation protocols, and participate in Analytical Method Transfer and OpEx projects.
* Foster a safety culture, ensure regulatory compliance, and communicate non-conformance, instrument malfunctions, or accidents to supervisors.
Essential Knowledge & Experience
* Strong knowledge of GMP, Pharmacopeia, regulatory requirements, and analytical chemistry with a commitment to continuous learning.
* Expertise in Lean Six Sigma, data analysis, and using data-driven decisions to improve efficiency and minimize costs.
* Leadership, planning, problem-solving skills, and the ability to drive improvements and new initiatives.
* Proficient in audit preparation, inspection, and managing stakeholders across key interfaces.
* High proficiency in HPLC required.
Education
* Minimum bachelor’s degree in Science/Chemistry or related field or equivalent.
Additional Information
* This is a two-year fixed-term contract.
* Position is based in Dublin – Ireland.
* This position requires you to be 100% on-site/in 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.
Seniority level
* Seniority level
Entry level
Employment type
* Employment type
Contract
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing
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