QC Senior Compliance Specialist

MeiraGTx; Ireland; On-site; EUR 70,000 - 110,000; Full time

Job summary

MeiraGTx is seeking a QC Senior Compliance Specialist to ensure GMP-compliant activities within QC supporting gene therapy product manufacture. You will review and approve QC documentation to support batch release and drive KPI reporting.

You will coordinate stability records, support investigations, and work with QC teams to close CAPAs, deviations, and change controls within timelines. Strong attention to detail and data integrity are essential.

Qualifications

• Minimum 4 years experience working in QC or QA GMP environment.
• Experience of quality documentation review and approval (QC/Manufacturing batch records).
• Proficiency in Microsoft Office software (Word, Excel and PowerPoint).

Responsibilities

• GMP Compliance activities in QC.
• Management of audit schedule.
• Quality record KPI tracking and reporting.

Education

Degree in a scientific discipline

Tools

MS Office

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)