Your mission
To Manage the Ireland Materials team and support Good Manufacturing Practice (GMP)-compliant activities for the QC release of product and incoming materials.
Review and Approve QC documentation to support QC batch release.
Support QC manager in other activities where requested.
Job Description
Major Activities
Team Leader- Review and approve Quality Control documentation ensuring timely and adequate release of GMP compliant product in accordance with product specifications.
- Provide line management to member(s) of the incoming material inspection department to contribute to the overall group objectives.
- Plan and assign work to the team to achieve the most efficient use of personnel and resources.
- Overseeing the incoming material inspection department to support the seamless supply of materials for the manufacture of drug product.
- Ensure all direct reports or persons involved in projects are fully trained and maintain a high standard of record keeping and documentation so that information is clearly captured, disseminated, and reported.
- Support the development and implementation of quality control documentation/continuous improvement programmes.
- Contribute to the training and development of others.
- 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 and technical input where needed.
- Assure the data integrity of all activities performed.
- Ensure area compliance with Quality, Safety and Environmental systems and procedures.
Materials department
- Perform inspection, and release of incoming materials, following SOPs and GMP practices to ensure seamless supply of material to support aseptic manufacture of ATMP product.
- Set up, Control, and monitor the material inspection programme ensuring materials are suitable for the manufacture of gene therapy products to the required standards.
- Physical inspection of raw materials. Ensure the warehouse storage environment is acceptable for the materials being inspected (Can be multiple warehouse locations).
- Set up, monitor, and coordinate incoming material testing where required.
- Maintain all incoming material documentation meets GMP requirements.
- Ensure adequate control of the material status for release or reject.
- Comply with MeiraGTx procedures including Health and safety and GMP.
- To ensure all equipment used is calibrated/maintained and in line with SOP’s.
- Identify and report procedural problems and deviations.
- Participate in the planning of duties to ensure the facility is acceptable and customers receive products on time and in full.
- Any other duties/projects within the skills and ability of the post holder.
- Identify and support method/technology improvement activities and facilitate implementation into the microbiology department.
Key Performance Indicators
HR process compliance
Staff turnover rate
Material release KPIs
GMP compliance
Data integrity
Key Job Competencies
- Experience of working within a GMP manufacturing 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.
- Physical & mental requirements - occasional lifting; the noise level in the work environment is usually moderate.
Job ResponsibilitiesTeam of Materials Scientists/Technicians
Compliance with GMP
- Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
- Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner before the task is undertaken.
- Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a RFT state.
Job Background
- Supervisory and/or management experience of people and/or processes.
- Minimum 3 years’ experience working in a GxP environment.
- Experience of quality documentation and batch release.
- Proficiency in Microsoft Office software (Word, Excel, and PowerPoint) preferred.
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