QC Senior Compliance Specialist

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.  - Review and Approve QC documentation to support QC batch release. - Generate, track and report on QC quality metrics. - Drive quality improvement projects within the QC department. - Support QC Managers/QC Team Leads in other activities where requested. Major Activities - Review and approve Quality Control documentation ensureing timely release of GMP compliant product in accordance with product specifications promoting right first time initiative - Coordination of stability records to ensure timely batch release - Tracking and supporting of OOS Investigations to ensure timely closure - Create, Track, trend and report QC KPI’s  - To support the QC team with quality Investigations for timely closure if Quality events. - Work closely with QC team leaders to ensure Quality Management documents (Change Requests, CAPA’s, Deviations) are completed within the given timelines - Track and manage the documentation periodic reviews and ensure their completion in line with site procedures - To generate SOT & CofA’s to support batch release - To be responsible for conducting Area Inspections within the quality control group, ensuring compliance is maintained at all times - Coordinate with team leads the group training activities within the Qualtiy Control group to ensure GMP compliance - Propose and/or Support the development and implementation of continuous improvement programmes - Promote appropriate, effective communication within the team, with members of other departments, and with external collaborators - Contribute to cross departmental activities and providing expert advice where needed - Assure the data integrity of all activities is performed - Identify and report procedural problems and deviations - Ensure area compliance with Quality, Safety and Environmental systems and procedures - Comply with MeiraGTx procedures including Health and Safety and GMP - 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  Key Performance Indicators - GMP compliance  - Quality Control KPI’s - Data integrity  Key Job Competencies - Experience of working within a quality environment - Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness - A high Level of attention to detail - 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 - Leadership - exhibits confidence in self and others when leading a team of people and managing processes - Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence;  - Planning/Organizing - prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives - 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 - Innovation - meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas - Oral Communication - speaks clearly; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings - 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 Job Responsibilities - GMP Compliance activities - Management of audit schedule - Quality record KPI tracking and reporting Job Background - Degree in a scientific discipline - Minimum 4 years experience working in QC or QA GMP environment - Experience of quality documentation review and approval e.g. QC or Manufacturing batch records - Experience of quality record documentation review and approval e.g. Deviations, CAPA, change control - Proficiency in Microsoft Office software (Word, Excel and PowerPoint)