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)
Job details are sourced from the employer's original posting.
