Qualified Person - QP

Your mission is to undertake the duties and responsibilities of the Qualified Person as defined in Directives 2001/83/EC and 2001/20/EC. Act as GMP Subject Matter Expert (SME) to facilitate site compliance with the company’s Quality Management system. Ensure systems are identified and in place to maintain compliance with current established GxP standards. Support senior QA leadership through QP decision making to drive continuous improvement and compliance.

Major Activities:

• Ensure batches are manufactured and tested to GMP and in line with the CTA/IND and PSF.
• Review completed batch records and complete batch dispositions.
• Develop and own the batch release process.
• Provide QA oversight, technical QA expertise and leadership across all aspects of GMP Operations from Manufacturing, Tech Transfer through Warehouse activities, Engineering, Quality Control, Supply Chain and Operations support.
• Identify, communicate, and elevate quality and compliance risks.
• Provide direction for and participate in timely resolution, acting always with an appropriate sense of urgency.
• Attend and participate in the Quality Management Review meetings.
• Ensure that complaints, deviations, and any significant quality incidents are thoroughly reviewed and closed out in a timely manner.
• Ensure changes are appropriately managed.
• Approval of procedures and policies.
• Work as part of the MeiraGTx team to undertake continuous improvement of business quality systems.
• Advise and participate in projects from a quality assurance perspective.
• Keep up to date with regulatory changes and developments, aiding the transition into company SOPs and processes.
• Assist with regulatory inspections providing SME support.
• Assist in the remediation of regulatory findings and closure of deficiencies.
• Support self-inspection process, providing coaching to self-inspection auditors and review of the outcomes of audits.
• Strong interpersonal skills must have the ability to establish and maintain effective working relationships with internal and external peers and stakeholders.
• Experience of leading/participation in EU and US competent authority inspections.

Key Job Competencies:

• Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
• Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
• Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state.