Company: hVIVO PLC
Closing Date: 02 Dec 16
Type: Full Time
Salary (£): 40,000 - 60,000
Benefits: pension, life, health and Bonus
We are a world-leading life sciences company dedicated to the study of the Human Challenge Model (HCM), an extensive scientific analysis of how viruses and other illnesses behave in the human body. At hVIVO, our approach is radically simple. We develop human models of disease that enable organisations to discover better drugs and diagnostics and accelerate new product development, whilst shortening time to market.
Provide QA advice and support in relation to GCP, GCP for laboratories, computer
systems validation and regulatory compliance to all areas of the business to
ensure hVIVO are compliant with GCP regulations and guidelines. Provide advice
and guidance to the business on interpretations of best practice and lead cross
functional projects to drive continual quality improvement.
Develop, manage and deliver a high standard GCP training programme across all
hVIVO sites ensuring both the needs of the company and regulations are met.
Conduct QA audits of internal processes and of hVIVO suppliers in order to
provide confidence in the quality of the data generated and subject safety
~~Act as an expert source of advice and guidance on all GXP and quality
management system related quality issues and keep abreast of legislation
and ensure both staff and management are regularly updated in current
GXP regulations and guidelines and any potential impact on the business;
· Management and implementation of continual process improvement of
RQG and hVIVO systems;
· Coordinate with Sponsor auditors to build trust and confidence in hVIVO
· Oversee the management and implement continual process improvement
of hVIVO systems;
· Lead cross functional and interdivisional/ departmental projects to improve
compliance and quality;
· Manage the GCP training programme across hVIVO to ensure compliance
with GCP regulations;
· Manage and delegate assigned ad hoc projects as required and coordinate
with other divisions to ensure their delivery;
Queen Mary BioEnterprises Innovation Centre 42 New Road, London,
|Tel:||+44 (0) 20 7756 1300|
|Website:||Visit Our Web Site|
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