Major Activities and Responsibilities:

• Provide management oversight of the QA operations shift ensuring team covers the 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 QA Processes. Create 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, Change Controls and temperature excursions.
• Create and review Risk reporting and Mitigation.
• 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
• Responsible for ensuring that own work ad that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
• Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner before the task is undertaken
• Responsible for ensuring that any GMP documentation assigned to me and my team e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state

Key Job Competencies

• Experience of working within a sterile GMP manufacturing environment.
• Excellent understanding of Quality Management Systems.
• Proficient in Microsoft Office and experience in database use and eQMS systems.
• Excellent interpersonal skills
• Good organisational and time management skills and able to demonstrate flexibility and adaptability.
• Able to prioritise workload, decisive thinker able to work within agreed timescales.
• A high Level of attention to detail.
• Knowledge of GCP and GMP with regards to QMS activities
• Good team player and must also be able to work alone.
• Experience in Competent authority, Regulatory body inspections and audits.
• Ability to manage a team

Job Responsibilities

• Support the training and coaching of the QA operations team

Job Background

• Experience working in a GxP 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