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PROJECT DESCRIPTION We are seeking experienced Remediation Quality Engineers / Manufacturing Engineers to support a site-wide remediation program following an FDA 483.
These roles will focus on manufacturing process validation, quality system updates, and documentation remediation.
Consultants will be based onsite and work directly with manufacturing and quality process owners to identify compliance gaps, implement corrective actions, and ensure documentation is accurate and audit-ready.
The project will involve tackling remediation areas in sequence, updating technical files and procedures, and ensuring robust validation of manufacturing processes.
Consultants must be able to take a problem statement through to a compliant solution, collaborating cross-functionally across Quality, Manufacturing, and Regulatory teams.
PROJECT DESCRIPTIONPartner with process owners on the floor to capture and remediate issues.Support process validation (IQ/OQ/PQ) and documentation updates.Drive CAPA/NCR closure and implement compliant solutions.Provide technical writing for quality and manufacturing documents.Collaborate cross-functionally to ensure regulatory compliance.
CONSULTANT RESPONSIBILITIESEngineering or Quality degree with 5-10 years' med-tech experience.Background in remediation, process validation, CAPA, NCRs.Strong technical writing and documentation skills.Knowledge of 21 CFR Part 820, ISO *****.LOCATION: Cork