Your mission As the QC Senior Compliance Specialist, you will be responsible for ensuring continued Good Manufacturing Practice (GMP)-compliant activities within QC to support the manufacture of gene therapy products. <ul><li>Review and Approve QC documentation to support QC batch release.</li><li>Generate, track and report on QC quality metrics.</li><li>Drive quality improvement projects within the QC department.</li><li>Support QC Managers/QC Team Leads in other activities where requested.</li></ul> Job Description <h3>Major Activities</h3><ul><li>Review and approve Quality Control documentation ensureing timely release of GMP compliant product in accordance with product specifications promoting right first time initiative</li><li>Coordination of stability records to ensure timely batch release</li><li>Tracking and supporting of OOS Investigations to ensure timely closure</li><li>Create, Track, trend and report QC KPI’s </li><li>To support the QC team with quality Investigations for timely closure if Quality events.</li><li>Work closely with QC team leaders to ensure Quality Management documents (Change Requests, CAPA’s, Deviations) are completed within the given timelines</li><li>Track and manage the documentation periodic reviews and ensure their completion in line with site procedures</li><li>To generate SOT & CofA’s to support batch release</li><li>To be responsible for conducting Area Inspections within the quality control group, ensuring compliance is maintained at all times</li><li>Coordinate with team leads the group training activities within the Qualtiy Control group to ensure GMP compliance</li><li>Propose and/or Support the development and implementation of continuous improvement programmes</li><li>Promote appropriate, effective communication within the team, with members of other departments, and with external collaborators</li><li>Contribute to cross departmental activities and providing expert advice where needed</li><li>Assure the data integrity of all activities is performed</li><li>Identify and report procedural problems and deviations</li><li>Ensure area compliance with Quality, Safety and Environmental systems and procedures</li><li>Comply with MeiraGTx procedures including Health and Safety and GMP</li><li>Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures</li><li>Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken</li><li>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</li></ul> Key Performance Indicators<ul><li>GMP compliance </li><li>Quality Control KPI’s</li><li>Data integrity</li></ul> Key Job Competencies<ul><li>Experience of working within a quality environment</li><li>Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness</li><li>A high Level of attention to detail</li><li>Problem Solving - Identifies and resolves problems in a timely manner; able to gather and analyse information; develops alternative solutions; works well in group problem solving situations</li><li>Leadership - exhibits confidence in self and others when leading a team of people and managing processes</li><li>Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence; </li><li>Planning/Organizing - prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives</li><li>Professionalism - approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments</li><li>Innovation - meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas</li><li>Oral Communication - speaks clearly; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings</li><li>Written Communication - writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information</li></ul> <h3>Job Responsibilities</h3><ul><li>GMP Compliance activities</li><li>Management of audit schedule</li><li>Quality record KPI tracking and reporting</li></ul> Job Background<ul><li>Degree in a scientific discipline</li><li>Minimum 4 years experience working in QC or QA GMP environment</li><li>Experience of quality documentation review and approval e.g. QC or Manufacturing batch records</li><li>Experience of quality record documentation review and approval e.g. Deviations, CAPA, change control</li><li>Proficiency in Microsoft Office software (Word, Excel and PowerPoint)</li></ul>

QC Senior Compliance Specialist @ meiragtx

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