Company: Hydrogen Group
Closing Date: 09 Dec 16
Salary (£): Negotiable
This is an opportunity to work for on eof the worlds leading Pharmaceutical companies in the world to ensure an adequate quality and regulatory intelligence programme which is in place to assess regulations and inspection trends and results, and ensure comments to regulations are provided to Health Authorities, in collaboration with Vaccines Advocacy and in line with companies Corporate Quality.
* Define and implement mechanisms to ensure the maintenance and improvement of the quality and regulatory intelligence program across the Global Functions and manufacturing sites.
* Maintain documentation and associated tools to support the quality and regulatory intelligence program
* Proactive searching, monitoring, tracking and dissemination of quality and regulatory intelligence to ensure that intelligence is efficiently analyzed, shared, communicated and acted upon by the organization to effectively achieve the company's regulatory compliance goals and objectives.
* Establish and maintain, as needed, a network of site quality/intelligence Subject Matter Expert’s across the organization to share learning’s and best practices and support on improvement initiatives.
* Liaise with advocacy practitioner and SME networks to understand and manage intelligence which may impact the manufacture and control of vaccines and related activities and inform management on potential impact.
* Track key developments from health authorities, trade associations, special interest groups and other external parties to understand external trends on GMPs and regulations and provide advice to global & site GIO/Q functions.
* Ensure timely escalation of critical Good Manufacturing Practices/Good Distribution Practices compliance/regulatory risks and gaps.
30 Eastcheap London
|Tel:||+44 (0) 207 002 0000|
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