Senior QA Associate

Your mission

• 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. 

Job Description

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.
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