Senior QA Associate

Your missionProvide experienced QA support and oversight to MeiraGTx operations.

• Ensure QA regulatory compliance and product quality.

Requisitos

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 DescriptionMajor Activities and

Responsabilidades

: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 ask.