Senior QA Associate

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 - Supports innovation by challenging outdated practices and encouraging better ways of working.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