Quality Assurance

We are seeking a Quality Assurance Specialist to join a company based in Bray. WHAT WE OFFER * Salary between €50,000 - €60,000 a year depending on experience * Health insurance and wellness programs. * Retirement savings plan and employee assistance program. * Opportunities for professional development and career advancement. RESPONSIBILITIES * Review and approve manufacturing documents, including batch records, standard operating procedures (SOPs), and specifications, to ensure compliance with regulatory requirements and quality standards. * Conduct internal audits and inspections to assess compliance with Good Manufacturing Practices (GMP) and other regulatory requirements. * Investigate deviations, non-conformances, and customer complaints, leading root cause analysis and implementing corrective and preventive actions (CAPAs) to prevent recurrence. * Perform risk assessments and quality risk management activities to identify and mitigate potential risks to product quality and patient safety. * Support validation activities, including process validation, equipment qualification, and cleaning validation, to ensure the reliability and consistency of manufacturing processes. * Provide guidance and training to manufacturing personnel on quality procedures, regulations, and best practices. * Collaborate with cross-functional teams, including manufacturing, regulatory affairs, and quality control, to address quality-related issues and drive continuous improvement initiatives. Minimum requirements: * 2+ years of experience in quality assurance, quality control. * Strong understanding of GMP regulations, ICH guidelines, and industry standards related to pharmaceutical manufacturing.

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