Quality Systems Expert
The Quality Systems Expert will provide QA oversight of the Pharmaceutical Quality System (PQS) whilst managing and support GMP issues through the PQS and site governance mechanisms to support Site operations and Senior QA leadership.
Key responsibilities:
- Use knowledge of GMP and quality processes to actively identify, suggest, participate in and manage continuous improvement to ensure that PQS remains effective, efficient, simple and compliant
- Monitor, analyze and interpret Site quality metrics and ongoing quality trends for risks and deviations to provide information to the Site.
- Ensure actions are taken in a timely manner to address trends and when issues are highlighted.
- Lead and support Site QMS governance processes
- Actively develop, mentor, train and enforce a site GMP culture within Operations.
- Support regulatory and customer audits of the Operations areas and processes
- Identify opportunities for GMP compliance training and awareness campaigns – design, develop and deliver.
- Drive continuous improvement and ‘fitness for purpose’ for the PQS.
- Deputise for PQS group lead
- Ensuring technical accuracy and GMP compliance
What we need you to have:
- Degree (or equivalent) in Biology.
Previous work experience in QA / GMP is essential - Experience working with Quality Systems such as Trackwise and Document management system.
- Experience managing Quality Records to completion
- Experience working with teams to make improvements the Quality management systems such as deviations
- Project management experience is desirable
- Demonstration of workload prioritisation skills, decision-making and scheduling skills.
- Ability to meet strict deadlines.
- Developing decision-making and problem-solving skills.
- Good organisational & planning skills.
- IT literate – MS Office – Word, Explorer, Excel, Access, Outlook.
- Database familiarity with data entry/searches/queries.