Job ID :
United Kingdom - Warrington
- Provide focus for the Quality Management System and work closely with all departments and functions to promote processes that ensure consistency, continuous improvement and compliance with quality and business requirements.
- Provide support for Quality Systems and maintain the appropriate level of customer service. Has the ability to write clear, coherent internal business communications / reports. Formally presents results of work.
- Non Conformance Reports and monitoring reporting performance and trends.
- Problem solve, identification of root cause and implementation / follow up of corrective procedures and preventive actions to ensure timely resolution of such problems.
- Ability to perform internal audits as required according to site and global plans.
- Use auditing as a proactive tool for improvement as well as compliance and challenge existing practice where appropriate.
- Timely completion and follow up through to closure of CAPA actions.
- Measuring and monitoring of performance against agreed KPIs.
- Collate and share information / data across the site as appropriate through reports and follows up on identified improvement opportunities.
- Actively contribute to the success of the overall QA team and the site.
- Actively participate and/or drives EU/Global QMS improvements as required.
- Degree in a scientific discipline or equivalent experience in a relevant discipline
- Knowledge of ISO 13485.
- Quality Assurance / Auditing experience in a chemical, pharma or manufacturing industry.
- Experience in the one of the following - training, validation, problem solving tools. Understanding of statistics based management & procedure is preferred.
- Excellent MS Office skills in particular Excel (Trackwise and Statistical Software or comparable experience)
- Ability to perform routine duties with minimum supervision.
- Ability to work on a variety of assignments at one time.
- Ability to recognize deviation from requirements and standard practice and understanding associated risks is essential in role.
- Good communication skills (spoken and written)