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Quality Assurance for Computer Systems Validation
Client:
Location: Tralee, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
db808380cbd1
Job Views:
35
Posted:
21.01.2025
Expiry Date:
07.03.2025
Job Description:
Description
Quality Assurance for Computer Systems Validation
About Astellas: 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.
The Opportunity:
As a Quality Assurance – (CSV) Computer System Validation, you will be primarily responsible for the implementation, execution, and assessment of quality systems, procedures, and records to support compliant GMP operations. Your responsibilities include ensuring adherence to relevant regulations and guidance documents, industry best practices, local regulations, and internal policies and procedures. You will work closely with Computer System Validation (CSV), Site Validation, Engineering, Manufacturing, Facilities, Document/Data Management, and other GxP supporting functions to ensure compliant computerized systems are deployed and maintained. This is accomplished by direct collaboration and oversight of CSV activities and the review/audit of data and reports specified by Standard Operating Procedures.
Key Responsibilities:
1. Provide hands-on QA support to internal staff and suppliers/contractors, ensuring compliance with SOPs and GxP requirements.
2. Collaborate with the CSV and Validation teams to define validation strategies for site-specific systems, including automation and computerized systems.
3. Review and approve commissioning and qualification documents, including validation plans, specifications, risk assessments, and protocols.
4. Ensure quality of CSV documentation in cGMP-regulated biologics manufacturing environments, focusing on 'Right the First Time' practices.
5. Author, review, and approve controlled documents, including SOPs, specifications, protocols, reports, and quality system records (Deviation, CAPA, Change).
6. Facilitate risk assessments, cross-functional team discussions, and support regulatory inspections (FDA, EMA, DHHS), while tracking and reporting quality metrics.
Essential Knowledge & Experience:
1. Able to clearly communicate and justify QA position and opinion in discussions on SDLC.
2. Ability to apply relevant regulatory knowledge, industry knowledge and own experience in a logical manner. Approaches all topics in a logical manner considering all perspectives and then making informed decisions.
3. Able to work with stakeholders globally and provide perspective from base region.
4. Can manage local QA projects with limited number of participants available. Can also contribute to larger cross functional projects representing QA.
Preferred Experience:
1. Experience of QA function in an aseptic manufacturing plant & previous CSV experience desired.
Education:
1. Science-based degree with experience in a cGMP compliance environment or equivalent.
Additional Information:
1. This is a permanent, full-time position.
2. This position requires you to be 100% site/office-based.
3. The position is based on-site in Tralee, Ireland.
What We Offer:
1. A challenging and diversified job in an international setting.
2. Opportunity and support for continuous development.
3. Inspiring work climate.
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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