Job Description

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.

• 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.

Job Description

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)