Quality Assurance Expert
The role involves delivering quality compliance and training activities within a clinical manufacturing facility as part of a small team responsible for good manufacturing practice quality compliance and training initiatives.
* Developing, monitoring, maintaining, and improving systems and processes used for quality compliance.
* Managing training systems and processes, including the roll out of global initiatives.
This role is pivotal in delivering excellent performance across safety, quality, supply, and cost fundamentals. It requires cross-site and cross-company liaison, including the implementation of global initiatives within the facility.
Key responsibilities include:
1. Ensuring documentation accuracy and compliance with regulatory agencies and quality standards by reviewing and overseeing change requests, manufacturing, and cleaning operations.
2. Leading the development and continuous improvement of systems to enhance compliance within the department, encompassing documentation life cycle management, training practices, SOP improvements, and process flows.
3. Conducting compliance inspections and audits, generating metrics, and trending data to inform decision-making.