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Job Details

CSV Specialist

Company: Hobson Prior
Location: CSV Specialist
Reference: OG2644
Closing Date: 23 Nov 17
Type: Contract
Salary (£): On Application
Benefits: £250-£500

Job Summary:

·         Prepare CSV Policy, SOPs, WI and forms/templates for all CSV processes required to be owned by Immunocore

Requirements:

KEY RESPONSIBILITIES
 

·         Prepare CSV Policy, SOPs, WI and forms/templates for all CSV processes required to be owned by Immunocore

·         For each GxP Computer System, assess the system and provide a complete set of the required documentation as recorded in the Validation Plan and considering the Risk Assessment

·         Provide advice to IT, as required, on all regulatory requirements

·         Perform CSV audits, as appropriate/required

·         Train staff on CSV requirements and processes

·         Prepare the Immunocore Master Validation Plan

 

Other
·         Must be able to hit the ground running

·         Work with minimal supervision

·         Work to a very high standard

PERSON SPECIFICATION

 Experience & knowledge
 Essential

·         At least five years’ experience of hands-on validation of a variety of computer systems

·         Excellent communication skills both verbal and written

·         Experience in performing audits (certified ISO Internal Auditor preferred but not essential)

·         Proven track record in producing quickly and efficiently CSV documentation

·         Ability to effectively project manage the initial validation of a system (preferable with proven track record)

·      

 

Desirable

·         Experience of validating laboratory equipment which include computer systems

 

 

 

 

 

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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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