The posting
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)
