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Job Details

Quality Assurance Manager -GCP, GXP

Company: hVIVO PLC
Location: London
Reference: 2016-2347
Closing Date: 02 Dec 16
Type: Full Time
Salary (£): 40,000 - 60,000
Benefits: pension, life, health and Bonus

Job Summary:

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

Quality Systems;

· 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;


Apply for this job: Quality Assurance Manager -GCP, GXP

Contact Information:

Address:  Head Office
Queen Mary BioEnterprises Innovation Centre 42 New Road, London,
E1 2AX
Tel:  +44 (0) 20 7756 1300
Website:  Visit Our Web Site

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