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Job Details

Global Clinical Trials Auditor

Company: Hobson Prior
Location: Home Based
Reference: FC458085
Closing Date: 27 Aug 17
Type: Contract
Salary (£): On Application
Benefits: £350-£450

Job Summary:

Quality manage and maintain oversight of the network of Clinical Trials Depots in line with applicable compliance standards, as well as key suppliers to the CTL business including (Packaging, Transport and other GxP critical suppliers).

Requirements:

Primary purpose of the role:

Quality manage and maintain oversight of the network of Clinical Trials Depots in line with applicable compliance standards, as well as key suppliers to the CTL business including (Packaging, Transport and other GxP critical suppliers).
This role will actively work with the RCR QA Manager (GMP), the Director CTL, CTL department Heads to quantify, measure and maintain a compliant status of the Global Clinical Trials Operation to ensure that quality services targets are met by the global network and that all Vendor/Suppliers are compliant to quality agreements and local health authority requirements.
This role will allow the delivery of successful project outcomes to provide CTL with a competitive advantage through a robust network of Global depots with a supplier base targeted on quality compliance.
This role will ensure that all client related non-conformances/deviations will be communicated, and impacted assessed in accordance with any Quality related impact in line with contractual obligations. It will be ensured that an investigation with a defined root cause has been documented and communicated to the specific client as week as internally to key stakeholders
 

General Accountabilities:

Undertake quality audits (as necessary) to ensure compliance to the client's audit schedule and recognised quality standards (yellow book and any applicable GxP regulations and recognised international standards).
Develop, monitor and manage Quality Performance Evaluations of all suppliers to Clinical Trials.
Assist with creation, adopt and maintain a standard vendor quality management process (communicating using appropriate tools and documentation) and external customers.
Work to a “one network” standard to ensure adoption of best practice in quality systems and operations.
Work closely with the Global Quality Team to ensure consistency of quality standards are driven through the depot network.
Ensure maintenance of validated status across the supplier base (including computer systems) network.
Authoring of high standard Audit and Quality Reports.
Detailing through audit observations and tracking to ensure timely close out by all depots and suppliers.
Training vendors in quality systems and processes for management and control (eQMS).
Regulatory, internal and external audit results.
Support the delivery of the Life Science Total Quality Plan.
Ensure Global Network Quality and Compliance with alignment to vendor audit cycle.
All quality risks identified or undergo root cause analysis, managed and contracted accordingly
Non – conformances (NCs): notifying clients of global non-conformances/ complaints in line with contractual obligations. Assessing non-conformances for impact on Product Quality, regulatory and supporting global operational teams to ensure NCs are thoroughly investigated and effective Corrective and Preventative Actions are implemented.

If this role is of interest to you please either use the link below or you can call me on 01892 612 612. Alternatively why not refer someone to us ?

 

 

 

 

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Apply for this job: Global Clinical Trials Auditor

Contact Information:

Address:  Hobson Prior International Ltd
Wellington Gate
7-9 Church Rd.
Tunbridge Wells
kent
TN1 1HT
England
Tel:  01892 612 612
Fax:  01892 612 613
Website:  Visit Our Web Site

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