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- Providing additional Quality Support & CI to support the operation
- Ensure full GDP compliance with regulations
- Complete quaility audits & risk assessments
- Providing QA oversight for the Doncaster site and maintaining thorough knowledge of applicable GDP regulations.
- Ensuring that all QA department activity is performed in accordance with defined procedures and appropriate records are maintained.
- Reporting into the QA Manager to review and update the QMS at regular intervals from a CI perspective.
- Ensuring that any complaints and deviations are appropriately recorded and investigated, with corrective actions are identified and communicated.
- Supporting in the management of any resultant finding and associated corrective actions from inspections.
- Complete risk assessments and quality internal audits.
- Ensuring documents and changes are managed, approved, controlled and reviewed.
- Performing internal and vendor audits.
- Reporting compliance through use of appropriate KPIs and information derived from our Quality systems.
- Experience of working in a similar distribution/pharmaceutical environment.
- Experience of developing & implementing processes and promoting change.
- Able to work autonomously and under pressure.
- Internal & external auditing.
- Strong communication skills with an ability to speak at all levels.
- Excellent ability to work under pressure and to tight time constraints.
- Excellent management, organisation and prioritisation skills.
