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 SOPs.
* 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.
* 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 are closed timely and in a RFT state.
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 Experience / Professional Background
* Minimum 1 years experience working in a GxP environment.
* Experience of quality documentation.
* Technical Experience required.
* Industry knowledge required.
* Compliance understanding/knowledge/guidelines requirements.
* Regulatory knowledge requirements.
* Software knowledge: Proficiency in IT, Microsoft Office software (Word, Excel and PowerPoint) essential.
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