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Quality Assurance for Quality Control
Client:
Astellas
Location:
Tralee, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
a21fef391108
Job Views:
34
Posted:
21.01.2025
Expiry Date:
07.03.2025
Job Description:
Description: Quality Assurance for Quality Control. 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 culture is one 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 while drawing inspiration from global insights and expertise. Our global vision for Patient Centricity supports the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity is a guiding principle for action. We believe all staff have a role in creating a patient-centric culture. 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.
The Opportunity: The role is part of the Quality Assurance function within the Astellas Ireland Co. Ltd. Tralee Plant Aseptic Manufacturing Facility. The Quality Assurance for Quality Control (QA for QC) role will be primarily responsible for the implementation, execution, and assessment of quality systems, procedures, and records to support compliant laboratory operations. This role will ensure adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. The QA for QC role will work closely with Quality Control, Validation, and other GxP supporting functions to ensure compliance. This is accomplished by direct collaboration and oversight of Quality Control activities and the review/audit of data and reports as specified by Standard Operating Procedures.
Responsibilities:
1. Build effective relationships between the QA team and stakeholders, ensuring clear quality requirements.
2. Provide hands-on QA support and oversight to staff, suppliers, and contractors, ensuring GxP compliance.
3. Oversee qualification of laboratory equipment, systems, and analytical method validation and transfer.
4. Manage temperature mapping and requalification requirements with QA oversight.
5. Review and authorize laboratory testing data, investigations, and QA approval for deviation investigations, including OOS and OOT results.
6. Author and approve controlled documents, track quality metrics, and ensure Quality Agreements are in place with vendors and customers.
Essential Knowledge & Experience:
1. Proficient in regional Good Manufacturing Practices (GMP) for pharmaceutical products.
2. Knowledgeable in the technology and computerized systems used in the manufacture and testing of biological products.
3. Experienced in pharmaceutical quality management systems (QMS), including tools like TrackWise, Valgenesis, and Vault.
Education:
1. Science-based degree with experience in a cGMP compliance environment, experience of QA function in an aseptic manufacturing plant, or equivalent.
Additional Information:
1. This is a permanent, full-time position.
2. Position is based in Tralee – Ireland.
3. 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.
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