Job Description
Clinigen is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, EU (Belgium, Germany, France), Asia Pacific and South Africa. Clinigen is growing rapidly and is positioned well for an exciting future of continued expansion.
To support our growth, we are seeking a diligent, detail-oriented and experienced Responsible Person to form part of our highly skilled quality team reporting into the licence holder. In this key role you will be responsible for safeguarding product users by ensuring GDP and minimising the risk of potential hazards in the supply chain.
You will have access to all areas, sites, stores and records which relate to the licensable activities and regularly review and monitor all such areas to ensure the necessary standards are achieved. You will have the authority to make decisions to ensure GDP compliance can be demonstrated and that all regulatory obligations are met.
Key Responsibilities, Not Limited To:
1. Primary host for client audits and responsible for the tracking and management of client audit actions
2. To ensure that the provisions of the wholesale distribution authorisation (WDA(H)) are observed
3. Ensure an adequa...