Position Summery:
We are seeking a dedicated, innovative person valuing Quality, with current expertise, passionate about enhancing QMS for cGMP compliance in Controlled Substances. In this role, you will play a crucial part in ensuring the safe and compliant management of controlled substances at our Swindon site.
Every day could be different leading and supporting a range of activities including risk management, internal & external audits, training, change control, deviations and CAPA, supplier assurance, document lifecycle, and metrics reporting. As process owner for one or more of these processes, we want someone to drive the ownership and accountability for process compliance. This will require staying up to date with standard processes, corporate and regulatory requirements.
A day in the life:
1. Responsibility for controlled substance management for the site CSP.
2. Collaborate with controlled substances regulators such as the Home Office.
3. By leading internal audits, you will support site inspection readiness whilst collaborating sitewide to ensure key objectives are efficiently achieved.
4. As a qualified trainer, share knowledge through structured training, particularly for controlled drug handling.
5. Draft, review, and approve diverse documents such as procedures, deviations, CAPA, etc. Successfully employ electronic tools (, Trackwise, eDMS, SFLMS) to assist site success in Quality systems and compliance duties.
6.