Job Description

Your mission

To manage incoming materials and support Good Manufacturing Practice (GMP) compliant activities for the QC release of product and incoming materials.
Support QC Materials Team in other acitvties where requested.

Major Activities

• Perform inspection of incoming materials, following SOPs and GMP practices to ensure seamless supply of material to support aseptic manufacture of ATMP product.
• 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).
• 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.
• Perform and support environmental monitoring activities for the sampling room, in line with GMP requirements, ensuring results are recorded and reported.
• Perform sampling of incoming raw materials, following SOPs and GMP practices to ensure seamless supply of material to support aseptic manufacture of ATMP product.
• 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.
• 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

• HR process compliance.
• 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 information; develops alternative solutions; works well in group problem solving situations.
• 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.
• 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 Responsibilities

• Compliance with GMP.
  
  

Job Background

• Minimum 1 years experience working in a GxP environment.
• Experience of quality documentation.
• Proficiency in Microsoft Office software (Word, Excel and PowerPoint) preferred.