Your mission <ul><li>Provide experienced QA support and oversight to MeiraGTx operations.</li><li>Ensure QA regulatory compliance and product quality requirements are met at all times, as well as facilitating product release in a timely manner. </li><li>Coach and train the QA team and other functions and continuously improve the local Quality system and provide training & support for Quality relevant systems. </li></ul> Job Description <h3>Major Activities and Responsibilities:</h3><ul><li style="font-size:14px;">Provide QA oversight to the manufacturing operation and supporting functions.</li><li style="font-size:14px;">Management of the MeiraGTx Quality Management System.</li><li style="font-size:14px;">Generation, Review and approval of relevant GMP documentation. </li><li style="font-size:14px;">Create and Review QA Processes. Create/review Standard Operating Procedures, Policies and Training material.</li><li style="font-size:14px;">Maintain QA KPI metrics.</li><li style="font-size:14px;">Collaborate with Operational areas, supporting the Team Lead to manage the day-to-day QA Operations.</li><li style="font-size:14px;">Review Batch documentation and support QA team review of Batch documentation. Ensuring timely and adequate release of GMP compliant product in accordance with Regulatory and site-specific authorisations.</li><li style="font-size:14px;">Manage and support QA team Facility Walk rounds and QA support for all operational areas.</li><li style="font-size:14px;">Provide direct quality team support during customer and regulatory audits.</li><li style="font-size:14px;">Perform internal audits and inspections and audit write up.</li><li style="font-size:14px;">Quality Systems: Complete Reporting, reviewing, investigating, root cause analysis, assessing Quality Risk Assessments, Incidents, Deviations, CAPA’s, OOS, Change Controls and temperature excursions.</li><li style="font-size:14px;">Support Document Management activities when required.</li><li style="font-size:14px;">Proactively initiate and support continuous improvement of the Quality Management System.</li><li style="font-size:14px;">Deliver compliance training to operational areas.</li><li style="font-size:14px;">Provide guidance and assistance to quality related issues in Operational areas and to External third parties.</li><li style="font-size:14px;">Deputise for the QA Team Leader – Operations when required.</li><li style="font-size:14px;">Proactive individual, able to step in without being asked. Identifies upcoming activities or tasks and works on completion without the need to be asked.</li><li style="font-size:14px;">Collaboration and stakeholder management.</li><li style="font-size:14px;">Adaptability ad resilience.</li><li style="font-size:14px;">Supports innovation by challenging outdated practices and encouraging better ways of working.</li><li style="font-size:14px;">Always asks and understands the “why” and is capable of explaining this to others. Does not automatically accept the status quo.</li><li style="font-size:14px;">Finds better ways for completing existing activities/processes saving time or effort while remaining compliant.</li><li style="font-size:14px;">Data driven decision making. Able to check reliability of sources, identify gaps, inconsistencies or misleading information.</li><li style="font-size:14px;">Demonstrates critical thinking and logical reasoning. </li></ul> <h3>Key Job Competencies and Behaviours</h3><ul><li>Minimum 5 years experience of working within a sterile GMP manufacturing environment.</li><li style="font-size:14px;">Excellent understanding of Quality Management Systems.</li><li style="font-size:14px;">Demonstrate very good understanding of the purpose of the regulation requirements in terms of how they translate to product quality and patient safety.</li><li style="font-size:14px;">Proficient in Microsoft Office and experience in database use and eQMS systems.</li><li style="font-size:14px;">Excellent interpersonal skills. Role model for professional behaviours, respectful relationships, positive and constructive communication.</li><li style="font-size:14px;">Capable of demonstrating structured thinking, data gathering and analysis for informed decisions.</li><li style="font-size:14px;">Good organisational and time management skills and able to demonstrate flexibility and adaptability. Capable of consistent on-time delivery of their individual tasks and responsibilities. Able to prioritise workload, decisive thinker able to work within agreed timescales.</li><li style="font-size:14px;">A high level of attention to detail.</li><li style="font-size:14px;">Good team player and must also be able to work independently.</li><li style="font-size:14px;">Strong experience in Regulatory inspections and Client audits.</li></ul> Job Background <ul><li style="font-size:14px;">Experience working in a Sterile manufacturing GMP environment including a minimum 5 years’ experience in Compliance and Quality Assurance.</li><li style="font-size:14px;">IT literate, experience managing and operating an electronic QMS.</li><li style="font-size:14px;">Excellent verbal and written communication skills.</li></ul>

Senior QA Associate @ meiragtx

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