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• Supports innovation by challenging outdated practices and encouraging better ways of working.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.