Description
QA Specialist - Dublin
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
The primary purpose of a Quality Assurance Specialist is to provide real-time support to manufacturing operations and support of the Quality Management System. This role is critical in driving a culture of cGMP and Quality diligence across the site, and representative of Astellas commitment to Quality as an integral part of our overall business objectives.
Key Responsibilities
* Partners with site management and staff to foster a culture of cGMP & Quality awareness, where the cGMP's and Quality are an integral part of the overall business.
* Provides effective real-time support for manufacturing including warehousing operations including batch record review, non-conformance management, Corrective and Preventative Actions (CAPA) development, lab investigations, change management, computer system change requests and complaint investigations.
* Support all aspects of the QMS e.g. APR's, supplier complaints, supplier qualification, data integrity, self-inspections, external audits, customer audits, regulatory inspections.
* Authors and maintains QA Standard Operating Procedures (SOPs) and reviews & approves site operations GMP procedures.
* Supports development and delivery of required GMP programs.
* Provide compliance oversight for computer system and facilities, utilities and equipment qualifications.
* Support the programs such as OPEX, World Quality Month etc. along with monitoring of metrics.
* Demonstrates high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained. Examines programs across the site to create efficiencies in practices and effectively drives for results and effectively network and communicate cross-site.
* Ensures compliance with relevant regulations and standards associated with ISO 14001, ISO45001, Health & Safety Legislation; Environmental Legislation; Astellas Quality Assurance standards, policies, and procedures.
Preferred Knowledge/Skills & Experience
* Strong knowledge of regulatory requirements related to pharmaceutical manufacturing.
* Able to work effectively using own initiative, have good organizational skills.
* Strong verbal and written communication skills; Ability to write in a technical tone.
* Ability to work independently without significant oversight or instruction to achieve results with a high degree of accuracy and attention to detail.
* Ability to explain and interpret information from internal and external sources.
* Proven track record of excellent judgment, problem resolution, teamwork, some budgeting and/or excel skills, decision-making skills, and the ability to work under pressure required.
* Proficient in MS Office Suite.
* Experience working in Quality Assurance or an equivalent role.
Educations
* Third-level qualification in Science or Engineering discipline with experience working in a GMP environment, or equivalent.
Additional Information
* This is a permanent position, based in the Dublin Plant and requires on-site work.
* This position is a key individual contributor role, with specialist knowledge in areas previously described.
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.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.