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Descrição da Função

Descrição We are looking for a Manufacturing QA Compliance Analyst for a healthcare company with a large activity scope. As a Manufacturing QA Compliance Analyst, you will provide real-time shop floor oversight to Aseptic operations, both manufacturing, sampling and testing, partnering with Site colleagues to create an environment of the highest performance standards of Aseptic operations and driving continuous improvement in Aseptic Operations on site. Responsabilidades - Act as site Subject Matter Expert for Aseptic Operations (Manufacturing, sampling and associated testing); - Ensures Aseptic operations are carried out as per Site Procedures; - Drives all aspects of Aseptic Performance of the shift team through observation and feedback, sampling and testing; - Partners with Aseptic Mentors and Shift Supervisors to drive performance of the shift team; - Supports training activities and actively coaches and mentors colleagues who work in Cleanrooms; - Provides Quality Oversight during critical Aseptic activities such as Cleaning, Sanitization, Aseptic Set-up, sampling, EM plate handling, sample testing and Interventions; - Participates and provides leadership to the Site Aseptics team, highlighting and leading introduction of continuous improvement in Aseptic procedures; - Provides input and guidance on changes related to Aseptic Manufacturing, sampling and associated testing; - Actively leads and supports investigations; - Reviews and Audits Manufacturing and Testing logs as required; - Completion of Line Clearance activities; - Participate in routine leadership GEMBAs of Manufacturing and Laboratory areas; - Provides key input to the development and maintenance of the Site Contamination Control Strategy; - Provides key input to the assessment of EM data and trends. Requisitos - Third Level Degree in a Science, Quality or Engineering discipline; - 5+ Years of experience in a GMP Environment with 3+ years of experience in support of Aseptic Manufacturing ideally; - Strong knowledge of Regulatory Requirements; - Excellent communication skills.

Localização

• Irlanda, Irlanda