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Quality assurance specialist (aseptic manufacturing)

Dublin
Recruitment by Aphex Group
Quality assurance specialist
Posted: 9 July
Offer description

12-month contract. Hybrid Position Are you an experienced Quality Assurance professional with expertise in aseptic manufacturing and process validation? Were looking for a Plant Technical Quality Assurance (PTQA) Specialist to join a dynamic team! Key Responsibilities: Act as the Quality point of contact for New Product Introductions (NPI), Tech Transfers, and Process Validation. Review & approve Process Development & Validation docs (tech transfers, protocols, reports). Provide Quality oversight for Change Control, Deviations, and CAPAs. Ensure compliance with safety standards & regulatory requirements. Collaborate cross-functionally to drive robust & timely implementation of quality processes. Requirements: 7+ years in pharma/biotech QA, with expertise in aseptic manufacturing & validation. Strong background in Change Control, Deviations, CAPA, and Process Validation. Ability to work independently & remotely with strong decision-making skills. Excellent communication, collaboration, and critical thinking abilities. Science/Engineering degree preferred. Skills: NPI Tech Transfers Process Validiation Quality Assurance

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