Job Summary:
Our world-renowned biopharmaceutical client is seeking QA Compliance & Systems Specialist on an initial 8-month contract for their best in class manufacturing facility based in West Dublin. Outstanding opportunity to support on both clinical and commercial products and grow ones experience rapidly with exposure to a wide array of tasks and responsibilities. If interested in discussing further reach out to myself today for a confidential conversation
Key Responsibilities:
1. Prepare, review, and approve material qualification documentation to ensure regulatory and procedural compliance.
2. Perform QA disposition for raw materials and Level 1 and Level 2 consumables to support timely manufacturing operations.
3. Coordinate with Supply Chain, QC, and Manufacturing to address material-related issues and ensure smooth release workflows.
4. Author, review, and approve QA-related procedures, work instructions, and supporting documentation.
5. Conduct QA review, assessment, and approval for quality system records, including change controls, deviations, investigations, supplier investigations, CAPAs, supplier change notifications (SCNs), TSE certificates, and other associated documentation.
6. Serve as a core member of the QA Compliance Materials Management team, contributing to departmental goals and cross-functional initiatives.
7. Support operational excellence activities such as 5S, Standard Work, Leader Standard Work (LSW), Kaizen events, and structured problem-solving.
8. Collaborate with internal stakeholders and external suppliers to resolve issues, strengthen compliance, and maintain material readiness.
9. Participate in audit readiness efforts and support regulatory inspection activities related to materials management and compliance processes.
Essential Requirements:
10. Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry) or related field.
11. Minimum of 3 years' experience in Quality Assurance or a similar role within a biologics or pharmaceutical manufacturing environment.
12. Strong understanding of cGMP principles, quality systems, and regulatory compliance requirements.
13. Ability to work independently as well as collaboratively across cross-functional teams in a fast-paced environment.
14. Excellent communication, presentation, time management, and organizational skills.
15. Demonstrated ability to manage multiple priorities and meet accelerated timelines.
16. Experience with material qualification processes and supplier quality oversight.
17. Working knowledge of SAP or similar ERP systems.
18. Familiarity with biologics manufacturing and raw material testing/requirements.
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